FrancophonIA/ELRC3.0 huggingface dataset:
English: • Periodic safety update reports(PSURs)
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: The efficacy of TachoSil was tested in a randomised controlled study in 726 patients (362 treated with TachoSil and 364 controls) undergoing skull base surgery as an adjunct to suture for sealing the dura mater, in which the efficacy outcome was measured post-operatively as verified cerebrospinal fluid (CSF) leaks or pseudomeningocoele, or treatment failure during surgery.
Croatian: Djelotvornost Tachosila kao dodatka šavovima za lijepljenje dure mater, ispitana je u randomiziranom kontroliranom ispitivanju na 726 bolesnika (362 u kojih je primijenjen Tachosil i 364 u kontrolnoj skupini) podvrgnutih operaciji baze lubanje, u kojem je ishod djelotvornosti mjeren postoperativno kao potvrđeno istjecanje cerebrospinalne tekućine ili pseudomeningokela, ili kao neuspjeh tijekom operacije.
English: Wipe the wound surface gently before placing TachoSil on the wound.
Croatian: Nježno prebrišite površinu rane prije stavljanja Tachosila na ranu.
English: There is very limited clinical data available regarding re-exposure to TachoSil.
Croatian: Klinički podaci o ponovnom izlaganju Tachosilu su vrlo ograničeni.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: 1 NAME OF THE MEDICINAL PRODUCT
Croatian: 1. NAZIV LIJEKA
English: However, in a clinical trial with TachoSil in hepatic surgery, in which patients were investigated for the development of antibodies, 26% of the 96 patients tested and treated with TachoSil developed antibodies to equine collagen.
Croatian: Međutim, u kliničkom ispitivanju primjene Tachosila u kirurgiji jetre, u kojem se kod bolesnika pratio razvoj antitijela, 26% od 96 ispitanika u kojih je primijenjen Tachosil razvilo je antitijela na konjski kolagen.
English: In this study two application techniques for TachoSil were evaluated: application of TachoSil over the dura and application of TachoSil on both sides of the dura.
Croatian: U ispitivanju su ocjenjivana dva načina primjene TachoSila: primjena Tachosila preko dure i primjena Tachosila s obje strane dure.
English: After removal of the pre-rolled TachoSil from the sterile package it should be applied immediately through the trocar without pre-moistening.
Croatian: Nakon vađenja prethodno zarolanog Tachosila iz sterilnog pakiranja, treba ga odmah primijeniti kroz troakar bez prethodnog vlaženja.
English: Clinical studies demonstrating haemostasis were conducted in a total of 240 patients (119 TachoSil, 121 argon beamer) undergoing partial liver resection surgery and 185 patients (92 TachoSil, 93 standard surgical treatment) undergoing surgical resection of superficial renal tumour.
Croatian: Postizanje hemostaze pokazano je kliničkim ispitivanjima provedenim na ukupno 240 bolesnika (119 TachoSil, 121 argonski laser) podvrgnutih djelomičnoj resekciji jetre, i na 185 bolesnika (92 TachoSil, 93 standardno kirurško liječenje) podvrgnutih resekciji površinskog tumora bubrega.
English: Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, gloves or adjacent tissues covered with blood.
Croatian: Zbog jakog afiniteta kolagena prema krvi, TachoSil se može zalijepiti i za kirurške instrumente, rukavice ili okolna tkiva prekrivena krvlju.
English: 4 CLINICAL PARTICULARS
Croatian: 4. KLINIČKI PODACI
English: TachoSil should be used immediately after opening the inner sterile cover.
Croatian: TachoSil se mora primjeniti odmah nakon otvaranja unutrašnjeg sterilnog pakiranja.
English: In clinical trials, the individual dosages have typically ranged from 1-3 units (9.5 cm x 4.8 cm); application of up to 10 units has been reported.
Croatian: U kliničkim ispitivanjima je pojedinačna doza najčešće bila u rasponu od 1-3 komada (9,5 cm x 4,8 cm); zabilježene su i primjene do 10 komada po bolesniku.
English: What is TachoSil used for?
Croatian: Za što se TachoSil primjenjuje?
English: TachoSil contains fibrinogen and thrombin as a dried coating on the surface of a collagen matrix.
Croatian: TachoSil sadrži fibrinogen i trombin u obliku suhog sloja na površini kolagenske matrice.
English: The doctor treating you will apply TachoSil during surgery.
Croatian: TachoSil će primijeniti liječnik tijekom kirurške operacije.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/haemostatics.
Croatian: Kod bolesnika liječenih fibrinskim ljepilima/hemostaticima mogu se u rijetkim slučajevima javiti preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, pečenje i probadanje na mjestu primjene, bronhospazam, zimica, navale crvenila, generalizirana urtikarija, glavobolja, koprivnjača, hipotenzija, letargija, mučnina, nemir, tahikardija, stezanje u prsištu, trnci, povraćanje, piskanje pri disanju).
English: Immunogenicity:
Croatian: Imunogenost:
English: The outer aluminium foil sachet may be opened in a non-sterile operating area.
Croatian: Vanjska vrećica od aluminijske folije se može otvoriti u nesterilnim uvjetima.
English: Each sealant matrix is packed in a PET-GAG blister sealed with a coated PE foil.
Croatian: Svaka matrica tkivnog ljepila pakirana je u PET-GAG blister zatvoren obloženom PE folijom.
English: This means that the TachoSil sticks to the tissue surface, the blood coagulates (local haemostasis) and the tissue is sealed.
Croatian: To znači da se Tachosil zalijepi za površinu tkiva, krv se zgrušava (lokalna hemostaza), a tkivo je zaljepljeno.
English: Once the foil sachet is opened, use immediately.
Croatian: Kad se aluminijska vrećica jednom otvori, primijenite odmah.
English: You may suffer hives, or a rash similar to nettle rash, chest discomfort or tightness, wheezing or low blood pressure.
Croatian: Moguća je pojava koprivnjače ili osipa nalik onom od koprive, stezanja ili nelagode u prsima, piskanja pri disanju ili niskog krvnog tlaka.
English: The size of the sealant matrix depends on the size of the wound.
Croatian: Veličina matricetkivnog ljepila ovisi o veličini rane.
English: Pre-moisten the flat TachoSil matrix in saline solution and place it on the wound immediately (if the wound is completely wetted by blood and other fluids, there is no need to moisten the matrix before application).
Croatian: Navlažite ravnu Tachosil matricu fiziološkom otopinom i odmah je položite na ranu (ako je rana potpuno vlažna od krvi i drugih tekućina, matricuprije primjene nije potrebno vlažiti).Prethodno zarolani Tachosil se ne smije vlažiti prije prolaska kroz troakar ili otvor.
English: During the following time TachoSil will dissolve and disappear.
Croatian: Tijekom narednog vremena će se Tachosil razgraditi i u potpunosti nestati.
English: It is recommended to remove the top part of the trocar prior to passing the pre-rolled TachoSil through the trocar.
Croatian: Preporučuje se ukloniti gornji dio troakara prije nego sekroz njega provuče prethodno zarolani Tachosil.
English: TachoSil is a sealant matrix made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.
Croatian: TachoSil je matricatkivnog ljepila od kolagena, koji je na žutoj strani obložen ljudskim fibrinogenom i ljudskim trombinom.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Croatian: Parvovirus B19 infekcija može biti opasna za trudnice (infekcija fetusa), za osobe čiji je imunološki sustav oslabljen ili za osobe s pojačanom eritropoezom (npr. s hemolitičkom anemijom).
English: Cleanse surgical instruments, gloves and adjacent tissues, if necessary.
Croatian: Očistitekirurške instrumente, rukavicei okolna tkiva,ako je potrebno.
English: A further controlled study in 119 patients (62 TachoSil, 57 haemostatic fleece) demonstrated sealing, haemostasis and suture support in patients undergoing cardiovascular surgery.
Croatian: Daljnjim kontroliranim ispitivanjem kod 119 bolesnika (62 TachoSil, 57 hemostatska mrežica) potvrđeno je lijepljenje, hemostaza i potpora šavovima kod bolesnika podvrgnutih kardiovaskularnoj kirurgiji.
English: In isolated cases, these reactions may progress to severe anaphylaxis.
Croatian: U izoliranim slučajevima takve reakcije mogu prerasti u tešku anafilaksiju.
English: Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Croatian: To se posebice događa ako se preparat primjenjuje više puta uzastopce, ili ga se primijeni kod bolesnika s poznatom preosjetljivosti na sastojke lijeka.
English: Once the foil sachet is opened, TachoSil must be used immediately.
Croatian: 3 godine Nakon otvaranja vrećice od folije, TachoSil se mora odmah primijeniti.
English: TachoSil may stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Croatian: TachoSil se može lijepiti za kirurške instrumente ili rukavice prekrivene krvlju.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Croatian: Znakovi reakcija preosjetljivosti uključuju koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju i anafilaksiju.
English: The quantity of TachoSil used depends on the size of the wound.
Croatian: Količina primijenjenog TachoSila ovisi o veličini rane.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Unatoč tome, kod primjene lijekova pripravljenih iz ljudske krvi ili plazme, mogućnost prenošenja infekcije ne može se u potpunosti isključiti.
English: TachoSil can be cut to the appropriate size and shaped to fit the wound.
Croatian: Tachosil se može izrezati u odgovarajuću veličinu i oblik kako bi odgovaraorani.
English: After removal of the conventional, flat TachoSil from the sterile package it should be pre-moistened in saline solution and then applied immediately.
Croatian: Nakon vađenja konvencionalnog, ravnog TachoSila iz sterilnog pakiranja, treba ga navlažiti u fiziološkoj otopini i odmah primijeniti.
English: The yellow, active side of the matrix is applied to the bleeding/leaking surface and held against it with a gentle pressure for 3-5 minutes.
Croatian: Žuta, aktivna strana matrice se nanosi na površinu koja krvari/curi i laganim pritiskom drži 3-5 minuta.
English: While unrolling the matrix the yellow, active side of the matrix is applied to the bleeding/leaking surface using e.g. a pair of cleansed forceps and held against it with a moist pad under gentle pressure for 3-5 minutes.
Croatian: Dok se matrica odmotava, aktivna žuta strana nanosi se na površinu koja krvari/curi korištenjem npr. očišćene pincete, te drži blago pritisnutim vlažnim jastučićem tijekom 3-5 minuta.
English: Hold down TachoSil with a gentle pressure for 3-5 minutes.
Croatian: Pridržite galaganim pritiskom 3-5minuta.
English: For smaller wounds, e.g. in minimally invasive surgery, the smaller sizes (4.8 x 4.8 cm or 3.0 x 2.5 cm) or the pre-rolled TachoSil (4.8 cm x 4.8 cm) is recommended.
Croatian: Za manje rane, npr.uminimalno invazivnoj kirurgiji, preporučuju se manje veličine (4,8 cmx 4,8 cm ili 3,0 cmx 2,5 cm), ili prethodno zarolani Tachosil (4,8 cmx 4,8 cm).
English: Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate (E331), L-arginine-hydrochloride
Croatian: Konjski kolagen, ljudski albumin, riboflavin (E101), natrijev klorid, natrijev citrat (E331), L-argininklorid
English: Thromboembolic complications may occur if the preparation is applied intravascularly (see section 4.4).
Croatian: Tromboembolijske komplikacije mogu se dogoditi ako se lijek primijeni intravaskularno (vidjeti dio
English: The following adverse reactions have been reported with TachoSil during post marketing experience.
Croatian: Sljedeće nuspojave prijavljene su za Tachosil nakon stavljanja lijeka u promet.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Unatoč takvim mjerama, pri primjeni lijekova proizvedenih iz ljudske krvi ili plazme, ne može se u potpunosti isključiti rizik prijenosa infekcija.
English: For smaller wounds, e.g. in minimally invasive surgery the smaller size matrices (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based on a matrix of 4.8 cm x 4.8 cm) is recommended.
Croatian: Za manje rane, primjerice u minimalno invazivnoj kirurgiji, preporučuju se matrice manjih dimenzija (4,8 cm x 4,8 cm ili 3,0 cm x 2,5 cm) ili prethodno zarolana matrica (bazirana na matrici od 4,8 cm x 4,8 cm).
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Croatian: Rijetko se mogu pojaviti antitijela na sastojke fibrinskog ljepila/hemostatika.
English: Place the yellow, active side of TachoSil against the wound.
Croatian: Položite žutu, djelatnu stranuTachosilana ranu.
English: ALUMINIUM-BONDED FOIL SACHET
Croatian: VREĆICA OD ALUMINIJSKE FOLIJE
English: Equine collagen Human albumin Riboflavine (E101) Sodium chloride Sodium citrate (E331) L-arginine-hydrochloride.
Croatian: 6.1 Popis pomoćnih tvari konjski kolagen ljudski albumin riboflavin (E101) natrijev klorid natrijev citrat (E331) L-argininklorid
English: TachoSil sealant matrix human fibrinogen/human thrombin
Croatian: TachoSil matrica tkivnog ljepila ljudski fibrinogen/ljudski trombin
English: Do not use intravascularly.
Croatian: Ne smije se primijeniti intravaskularno.
English: The product is available in different sizes and comes in packages with up to 5 units: Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Croatian: Lijek je dostupan u različitim veličinama i pakiranjima do 5 komada: Pakiranje sa 1 matricom od 9,5 cm x 4,8 cm Pakiranje sa 2 matrice od 4,8 cm x 4,8 cm Pakiranje sa 1 matricom od 3,0 cm x 2,5 cm Pakiranje sa 5 matrica od 3,0 cm x 2,5 cm Pakiranje s 1 prethodno zarolanom matricom od 4,8 cm x 4,8 cm
English: How to use TachoSil
Croatian: Kako primjenjivati Tachosil
English: To make sure that TachoSil does not cling to the moistened glove or swab, and loosens itself from the wound, TachoSil can be held down at one end e.g. by using a pair of forceps.
Croatian: Kako se Tachosilne bi zalijepioza vlažne rukavice ili tupfer i pomaknuos rane, možete gas jedne strane pridržati primjerice pincetom.
English: How to store TachoSil
Croatian: Kako čuvati Tachosil
English: 3 PHARMACEUTICAL FORM
Croatian: 3. FARMACEUTSKI
English: TachoSil sealant matrix.
Croatian: TachoSil matrica tkivnog ljepila
English: You should contact your doctor immediately if you discover any of these symptoms.
Croatian: Ukoliko otkrijete neke od navedenih simptoma odmah obavijestite Vašeg liječnika.
English: The un-rolled TachoSil should then be moistened at the site of application with a moist pad and held in place under gentle pressure for 3-5 minutes.
Croatian: Razmotani Tachosil se tada navlaži na mjestu primjene vlažnim jastučićem i pridrži laganim pritiskom 3-5 minuta.
English: 8 MARKETING AUTHORISATION NUMBER
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Package with 1 matrix of 9.5 cm x 4.8 cm Package with 2 matrices of 4.8 cm x 4.8 cm Package with 1 matrix of 3.0 cm x 2.5 cm Package with 5 matrices of 3.0 cm x 2.5 cm Package with 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Croatian: Pakiranje sa 1 matricom od 9,5 cm x 4,8 cm Pakiranje sa 2 matrice od 4,8 cm x 4,8 cm Pakiranje sa 1 matricom od 3,0 cm x 2,5 cm Pakiranje sa 5 matrica od 3,0 cm x 2,5 cm Pakiranje s 1 prethodno zarolanom matricom od 4,8 cm x 4,8 cm
English: But please note that the matrix should cover 1-2 cm beyond the margins of the wound.
Croatian: Matrica treba za 1-2 cmprelaziti rubove rane.
English: 5 PHARMACOLOGICAL PROPERTIES
Croatian: 5. FARMAKOLOŠKA SVOJSTVA
English: 1 matrix of 3.0 cm x 2.5 cm
Croatian: 1 matrica od 3,0 cm x 2,5 cm
English: CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany
Croatian: CSL Behring GmbH P.O. Box 1230
English: In addition, an updated RMP should be submitted
Croatian: AžuriraniRMP treba dostaviti
English: Life threatening thromboembolic complications may occur if the preparation is applied intravascularly.
Croatian: U slučaju intravaskularne primjene preparata mogu se dogoditi po život opasne tromboembolijske komplikacije.
English: 1 matrix of 4.8 cm x 4.8 cm
Croatian: 1 matrica od 4,8 cm x 4,8 cm
English: Sealant matrix
Croatian: Matrica tkivnog ljepila
English: 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Croatian: 1 prethodno zarolana matrica od 4,8 cm x 4,8 cm
English: 1 matrix of 9.5 cm x 4.8 cm
Croatian: 1 matrica od 9,5 cm x 4,8 cm
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Croatian: 5. NAČIN I PUT(EVI)PRIMJENE LIJEKA
English: EU/1/04/277/001 1 matrix of 9.5 cm x 4.8 cm EU/1/04/277/002 2 matrices of 4.8 cm x 4.8 cm EU/1/04/277/003 1 matrix of 3.0 cm x 2.5 cm EU/1/04/277/004 5 matrices of 3.0 cm x 2.5 cm EU/1/04/277/005 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Croatian: EU/1/04/277/004 5 matrica od 3,0 cm x 2,5 cm
English: - The active substances are human fibrinogen (5.5 mg per cm 2) and human thrombin (2.0 IU per cm - The other ingredients are equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331) and L-arginine-hydrochloride.
Croatian: Drugi sastojci su konjski kolagen, ljudski albumin, riboflavin (E101), natrijev klorid, natrijev citrat (E331) i L-argininklorid.
English: 1 matrix of 9.5 cm x 4.8 cm 2 matrices of 4.8 cm x 4.8 cm 1 matrix of 3.0 cm x 2.5 cm 5 matrices of 3.0 cm x 2.5 cm 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Croatian: 1 matrica od 9,5 cm x 4,8 cm2 matrica od 4,8 cm x 4,8 cm
English: TachoSil is an off-white sealant matrix.
Croatian: TachoSil je matrica tkivnog ljepila gotovo bijele boje.
English: CARTON
Croatian: Lijepljenje
English: TachoSil contains per cm Human Fibrinogen 5.5 mg Human Thrombin 2.0 IU For a full list of excipients, see section 6.1.
Croatian: 2) i ljudski trombin (2,0 IU po cm Djelatne tvari su ljudski fibrinogen (5,5 mg po cm
English: 18 October 2013
Croatian: 18. listopada 2013.
English: Article 35 of Directive 2001/82/EC, as amended
Croatian: Članak 35, Direktive 2001/82/EZ, s dopunama
English: Veterinary Medicines and Product Data Management
Croatian: Upravljanje veterinarsko-medicinskim proizvodima i podacima o proizvodima
English: International non-proprietary name (INN): dexamethasone
Croatian: Međunarodni nezaštićeni naziv (INN): deksametazon
English: The Committee appointed Dr C. Ibrahim as rapporteur and Dr D. Murphy as co-rapporteur.
Croatian: Odbor je imenovao Dr. C. Ibrahima kao izvjestitelja i Dr. D. Murphya kao pomoćnog izvjestitelja.
English: The final opinion was converted into a Decision by the European Commission on 18 October 2013.
Croatian: Zaključno mišljenje promijenjeno je u Odluku Europske komisije dana 18. listopada 2013.
English: Written explanations were provided by the marketing authorisation holders on 10 December 2012and 21 May 2013.
Croatian: Nositelji odobrenja dostavili su pisana pojašnjenja dana 10. prosinca 2012. i 21. svibnja 2013.
English: The referral started on 12 September 2012.
Croatian: Postupak upućivanja pokrenut je dana 12. rujna 2012.
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, antiallergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Croatian: Deksametazon je sintetski glukokortikoid dugog djelovanja koji se djeluje protuupalno, protualergijski i glukoneogenetski kod primjene na poljoprivrednim i domaćim životinjama.
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods.
Croatian: Na temelju ocjene trenutno dostupnih podataka, CVMP je zaključio da ukupan profil omjera koristi i rizika ovih VMP-ova ostaje pozitivan, no predmetom je izmjena u informacijama o VMP-u koje su povezane s usklađivanjem razdoblja karencije.
English: The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products thereof are solutions for injection which contain 2 mg dexamethasone per ml.
Croatian: Veterinarsko-medicinski proizvod Dexadreson 2 mg/ml i njegovi pridruženi nazivi i generički proizvodi otopine su za injekciju koje sadrže 2 mg deksametazona po ml.
English: The CVMP was requested to evaluate the adequacy and consumer safety of the withdrawal periods for meat in cattle and horses and the withdrawal periods for milk in cattle for the concerned products.
Croatian: Za dotične VMP-ove je od CVMP-a zatražena ocjena adekvatnosti i sigurnosti za potrošače razdoblja karencije za meso stoke i konja te razdoblja karencije za mlijeko stoke.
English: Therefore, the Committee adopted a positive opinion on 18 July 2013, recommending variations to the terms of the marketing authorisations for Dexadreson 2 mg/ml and its associated names and generic products thereof.
Croatian: Stoga je Odbor usvojio pozitivno mišljenje dana 18. srpnja 2013. godine preporučujući izmjene uvjete odobrenja za stavljanje VMP-a u promet za Dexadreson 2 mg/ml i njegove pridružene nazive te generičke proizvode ovog VMP-a.
English: Opinion following an Article 350F referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
Croatian: Mišljenje nakon postupka upućivanja sukladno članku 35.0F za Dexadreson 2 mg/ml i pridružene nazive, te njegove generičke proizvode
English: Opinion following an Article 351 referral for Dexadreson 2 mg/ml and associated names, and generic products thereof
Croatian: 35.1 za Dexadreson 2 mg/ml i pridružene nazive, te njegove generičke proizvode
English: On 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Dexadreson 2 mg/ml and associated names, and generic products thereof.
Croatian: Dana 22. kolovoza 2012., Njemačka je dostavila Agenciji obavijest o postupku upućivanja prema članku 35.
English: Cattle, cats, dogs
Croatian: Goveda, mačke, psi
English: However, the efficacy assessment does not fall within the scope of this referral procedure.
Croatian: Međutim, ocjena djelotvornosti ne ulazi u područje primjene ovog arbitražnog postupka.
English: Germany1 CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Croatian: Njemačka1 CP-Pharma Handelsgesellschaft mbH Ostlandring 13
English: Intramuscular or intravenous
Croatian: Intramuskularna ili intravenska primjena
English: These veterinary medicinal products are also authorised for use in dogs and cats, but considering the scope of the referral, these target species were not assessed during this procedure.
Croatian: Ti veterinarsko-medicinski proizvodi odobreni su za primjenu u pasa i mačaka, ali uzimajući u obzir područje primjene arbitražnog postupka, te se ciljane vrste nisu ocjenjivale u ovom postupku.
English: Zoetis France 23-25 Avenue du Dr Lannelongue 75014 Paris France
Croatian: Francuska Zoetis France 23-25 Avenue du Dr Lannelongue
English: In addition, the pharmacological ADI was exceeded up to 262 fold at day 7 and up to 2.8 fold at day 14.
Croatian: Nadalje, farmakološki ADI premašen je za 262 puta 7. dana, a 14. dana za 2,8 puta.