FrancophonIA/ELRC3.0 huggingface dataset:
English: Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg; Plasma Fibronectin 10-45 mg; Factor XIII 50-250 UI;
Slovenian: 1. komponenta: skupne beljakovine 500650 mg; koagulabilne beljakovine: 375575 mg, od tega fibrinogen 350-550 mg; plazemski fibronektin 10-45 mg; faktor XIII 50-250 i.e.; plazminogen: 0,2-0,6 mg; aprotinin 15000 EIK;
English: Thrombin (human) 500 I.E./ml Calcium chloride: 5,88 mg/ml
Slovenian: 2. komponenta: trombin (humani) 500 i.e./ml kalcijev klorid: 5,88 mg/ml
English: Human fibrinogen: 90 mg Coagulation factor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Calcium chloride: 5,9 mg
Slovenian: Humani fibrinogen: 90 mg Koagulacijski faktor XIII: 60 UI Aprotinin: 1000 KUI Trombin: 7,6 mg Kalcijev klorid: 5,9 mg
English: Thrombin S lyophilized: 500 I.E/ml Thrombin L lyophilized: 4 I.E/ml Calcium chloride: 5,88 mg/ml
Slovenian: 500 i.e./ml trombin L, liofiliziran: 4 i.e./ml kalcijev klorid: 5,88 mg/ml
English: Thrombin 500 IU or Thrombin 4 UI; Calcium Chlorid Dihydrate 5.88 mg
Slovenian: 2. komponenta: trombin 500 i.e. ali trombin 4 i.e.; kalcijev klorid dihidrat 5,88 mg
English: Combi-Set 1: fibrinogen: 90 mg/ml coagulation factor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
Slovenian: Combi-Set 1: fibrinogen: 90 mg/ml koagulacijski faktor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
English: Syringe TISSUCOL-APROTININ: Total Proteins 100-130 mg/ml; clottable protein 75-115 mg/ml, of which fibrinogen 70-110 mg/ml and plasmatic fibronectin 2-9 mg/ml: Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Aprotinin 3000 UIK/ml (1.67 UPE/ml); Syringe THROMBIN-CALCIUM CHLORIDE: Proteins 50mg/ml; Thrombin 500 UI/ml; calcium chloride 40 µmol/ml
Slovenian: Brizga TISSUCOL-APROTININ: skupne beljakovine 100130 mg/ml; koagulabilne beljakovine 75115 mg/ml, od tega fibrinogen 70-110 mg/ml in plazemski fibronektin 2-9 mg/ml: faktor XIII 10-50 i.e./ml; plazminogen 0,04-0,12 mg/ml; aprotinin 3000 EIK/ml (1,67 EEP/ml); Brizga TROMBIN-KALCIJEV KLORID: beljakovine 50 mg/ml; trombin 500 i.e./ml; kalcijev klorid 40 µmol/ml
English: Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg; Plasma Fibronectin 4-18 mg; Factor XIII 20-100 UI;
Slovenian: 1. komponenta: skupne beljakovine 200260 mg; koagulabilne beljakovine: 150230 mg, od tega fibrinogen 140-220 mg; plazemski fibronektin 4-18 mg; faktor XIII 20-100 i.e.; plazminogen: 0,08-0,24 mg; aprotinin 6000 EIK;
English: Fibrinogen: 90 mg/ml Aprotinin (bovine): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Factor XIII: 60 U/ml
Slovenian: Fibrinogen: 90 mg/ml Aprotinin (goveji): 1000 KIU/ml Trombin : 500 IU/ml Kalcijev klorid: 5,9 mg/ml Koagulacijski faktor XIII: 60 U/ml
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Slovenian: Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
English: ARTISS LYOPulver und Lösungsmittel für einen
Slovenian: ARTISS LYO - Pulver und Lösungsmittel für einen Gewebekleber
English: Total Protein 100-130 mg; Clottable protein: 75-115 mg, thereof Fibrinogen 70-110 mg; Plasma Fibronectin 2-9 mg; Factor XIII 10-50 UI;
Slovenian: 1. komponenta: skupne beljakovine 100130 mg; koagulabilne beljakovine: 75115 mg, od tega fibrinogen 70-110 mg; plazemski fibronektin 2-9 mg; faktor XIII 10-50 i.e.; plazminogen: 0,04-0,12 mg; aprotinin 3000 EIK;
English: The Netherlands Baxter B.V. Kobaltweg 49, Utrecht 3542 CE
Slovenian: 3542 CE Utrecht The Netherlands
English: Human Fibrinogen 91 gm/ml Human Factor XIII 10 IU/ml Bovine Aprotinin 3000 IU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 micromol/ml
Slovenian: humani fibrinogen 91 mg/ml humani faktor XIII 10 i.e./ml goveji aprotinin 3000 EIK/ml humani trombin 500 i.e./ml kalcijev klorid 40 mikromol/ml
English: Fibrinogen: 70 - 110 mg/ml Fibronectine 2 - 9 mg/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10-50 IU/ml Aprotinine (bovine): 3000 KIU/ml
Slovenian: fibrinogen: 70-110 mg/ml fibronektin: 2-9 mg/ml trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml faktor XIII: 10-50 i.e./ml aprotinin (goveji): 3000 EIK/ml
English: Human fibrinogen: 90 mg/ml Coagulation factor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Thrombin: 7,6 mg/ml Calcium chloride: 5,9 mg/ml
Slovenian: Humani fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Trombin : 7,6 mg/ml Kalcijev klorid: 5,9 mg/ml
English: Human fibrinogen (72-110 mg/ml) Factor xiii (≤10 UI) Aprotinin (3000 KUI2/ml) Human thrombin (500 UI3/ml) Calcium chloride (40micromol/ml)
Slovenian: Tisseellyo humani fibrinogen (72110 mg/ml) faktor XIII (≤10 i.e.) aprotinin (3000 EIK2/ml) humani trombin (500 i.e.3/ml) kalcijev klorid (40 mikromol/ml)
English: Human Fibrinogen 91 mg/ml Aprotinum INN 3000 KIU/ml (bovine) Human Thrombin 4 ae^3/ml Calcium Chloride 40 micromol/ml
Slovenian: Artiss humani fibrinogen 91 mg/ml aprotinin 3000 EIK/ml (goveji) humani trombin 4 i.e.^3/ml kalcijev klorid 40 mikromol/ml
English: The Netherlands CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Slovenian: Nizozemska CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
English: Fibrinogen:70-110 mg/ml Coagulation factor XIII: 10-50 I.E./ml Plasmafibronectin: 2-9 mg/ml Aprotinin (bovin): 3000 KIE/ml
Slovenian: 1. komponenta: fibrinogen: 70-110 mg/ml koagulacijski faktor XIII: 1050 i.e./ml plazemski fibronektin: 2-9 mg/ml aprotinin (goveji): 3000 EIK/ml
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Thrombin: 500 IU /ml Calcium chloride (dihydrate): 5,9 mg/ml
Slovenian: Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Trombin : 500 IU /ml Kalcijev klorid dihidrat: 5,9 mg/ml
English: Fibrinogen: 70-110mg/ml Plasmafibronectin (CIG): 2-9mg/ml Factor XIII: 10-50 U/ml Plasminogen: 0.04 - 0.12mg/ml
Slovenian: TISSEEL KIT 2.0 ml, Two-Component Fibrin Sealant fibrinogen: 70-110 mg/ml plazemski fibronektin (CIG): 29 mg/ml faktor XIII: 10-50 e./ml plazminogen: 0,04-0,12 mg/ml dermalna uporaba
English: Human Fibrinogen: 91 mg1/ml Aprotinin: 3000 KIU2/ml Human Thrombin: 500 IU3/ml Calcium Chloride: 40 µmol/ml
Slovenian: Tisseel humani fibrinogen: 91 mg1/ml aprotinin: 3000 EIK2/ml humani trombin: 500 i.e.3/ml kalcijev klorid: 40 μmol/ml
English: Human fibrinogen: 72-110 mg/ml Factor xiii: ≤10 UI Aprotinin: 3000 KU12/ml Human thrombin: 500 UI3/ml Calcium chloride: 40 micromol/ml
Slovenian: Tisseel humani fibrinogen: 72-110 mg/ml faktor XIII: ≤10 i.e. aprotinin: 3000 EIK2/ml humani trombin: 500 i.e.3/ml kalcijev klorid: 40 mikromol/ml
English: Aprotinin 3000KIE/ml Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml Thrombin human 500 IE/ml Calcium Chloride Dihydrate 40 μg/ml
Slovenian: Tisseel Duo Quick fibrinogen 90 mg/ml fibronektin 6 mg/ml aprotinin 3000 EIK/ml koagulacijski faktor XIII 30 i.e./ml plazminogen 80 μg/ml trombin, humani 500 i.e./ml kalcijev klorid dihidrat 40 μg/ml intralezijska uporaba
English: Human fibrinogen 72-110 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 µmol/ml
Slovenian: Tisseel solutions for sealant humani fibrinogen 72110 mg/ml aprotinin 3000 EIK/ml humani trombin 500 i.e./ml kalcijev klorid 40 µmol/ml
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
Slovenian: Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Trombin : 500 UI/ml Kalcijev klorid dihidrat: 5,9 mg/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10 IU/ml
Slovenian: Tisseel fibrinogen: 91 mg/ml aprotinin: 3000 EIK/ml trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml faktor XIII: 10 i.e./ml
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5.9 mg/ml
Slovenian: Fibrinogen: 90 mg/ml Koagulacijski faktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Trombin : 500 IU/ml Kalcijev klorid: 5.9 mg/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU Thrombin: 500 UI/ML Calcium Chloride: 40 MMO LI/L Factor XIII ≤ 10 UI/ml
Slovenian: fibrinogen: 91 mg/ml aprotinin: 3000 EIK trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml faktor XIII ≤10 i.e./ml
English: Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Slovenian: Artiss solution for sealant frozen humani fibrinogen 91 mg/ml aprotinin 3000 EIK/ml humani trombin 4 i.e./ml kalcijev klorid 40 µmol/ml
English: Bottle 1: Total Proteins 100-130 mg/ml; dont clottable protein 75-115 mg/ml, Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Bottle 2: Aprotinin bovine 3000 UIK/ml (1.67 UPE/ml);
Slovenian: Tissucol Kit steklenica 1: skupne beljakovine 100-130 mg/ml; koagulabilne beljakovine 75115 mg/ml, faktor XIII 1050 i.e./ml; plazminogen 0,040,12 mg/ml; steklenica 2: aprotinin, goveji 3000 EIK/ml (1,67 EEP/ml); steklenica 3: humani trombin 500 i.e./ml; beljakovine 50 mg/ml; steklenica 4: humani trombin 4 i.e./ml; beljakovine 50 mg/ml; steklenica 5: kalcijev klorid 40 µmol/ml
English: Aprotinin (bovel) 3000 KIU Plasminogen 80 microgram Thrombin solution per ml Human thrombin 500 ae Calcium chloridum 40 micromol
Slovenian: Tisseel raztopina na mlfibrinogen 90 mg fibronektin 5,5 mg faktor XIII 30 i.e. aprotinin (goveji) 3000 EIK plazminogen 80 mikrogramov Raztopina trombina na ml humani trombin 500 i.e. kalcijev klorid 40 mikromol
English: Fibrinogene humain (proteines coagulables) 72-110 mg/ml Facteur XIII ≤ 10 UI/ml Aprotinine 3000 UIK/ml Thrombine humaine 500 UI/ml Chlorure de calcium 40 μmol/ml
Slovenian: Tissucol S/D Kit humani fibrinogen (koagulacijske beljakovine) 72110 mg/ml faktor XIII ≤10 i.e./ml aprotinin 3000 EIK/ml humani trombin 500 i.e./ml kalcijev klorid 40 µmol/ml
English: Fibrinogen: 72-110mg/ml Aprotinin: 3000KIU/ml Thrombin: 500 IU/ml in 45-55mg total protein
Slovenian: TISSEEL Lyo, Two-Component Fibrin Sealant fibrinogen: 72-110 mg/ml aprotinin: 3000 EIK/ml trombin: 500 i.e./ml v 4555 mg skupnih beljakovin kalcijev klorid: 40 μmol/ml dermalna uporaba
English: Human fibrinogen: 91 mg/ml Aprotinin: 3000 KUI2/ml Human thrombin: 4 UI3/ml Calcium chloride: 40 mmol/ml
Slovenian: Artiss humani fibrinogen: 91 mg/ml aprotinin: 3000 EIK2/ml humani trombin: 4 i.e.3/ml kalcijev klorid: 40 mikromol/ml vehikel za lepilo za tkiva
English: Human Fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIU/ml Human Thrombin: 4 IU/ml Calcium Chloride: 40 μmol/ml
Slovenian: TISSEEL Lyo humani fibrinogen: 72-110 mg/ml aprotinin: 3000 EIK/ml humani trombin: 500 i.e./ml kalcijev klorid: 40 μmol/ml
English: Fibrinogen: 70 - 110 mg/ml Plasmafibronectin: 2 - 9 mg/ml Coagulation factor XIII: 10 - 50 I.E/ml Aprotininsolution: 3000 KIE/ml
Slovenian: 1. komponenta: fibrinogen: 70-110 mg/ml plazemski fibronektin: 2-9 mg/ml koagulacijski faktor XIII: 10-50 i.e./ml raztopina aprotinina:
English: Aprotinin 3000 UIK/ml (1.67 UPE/ml);
Slovenian: 3000 EIK/ml
English: Human fibrinogen: 110mg/ml Aprotinin: 3750KIU/ml Human thrombin: 6.5IU/ml Calcium chloride: 44mcmol/ml
Slovenian: Artiss, solution for sealant deep frozen humani fibrinogen: 110 mg/ml aprotinin: 3750 EIK/ml humani trombin: 5 i.e./ml kalcijev klorid: 44 μmol/ml
English: Adopted at the 8-11 January 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC, 8.-11. januarja 2018
English: The following side effects have also been reported:
Slovenian: Poročali so tudi o naslednjih neželenih učinkih:
English: What you need to know before you take [MTX] Warnings and precautions
Slovenian: Kaj morate vedeti, preden boste vzeti zdravilo [MTX] Opozorila in previdnostni ukrepi
English: Dulaglutide - Gastrointestinal stenosis and obstruction (EPITT no 18931)
Slovenian: Dulaglutid - gastrointestinalna stenoza in obstrukcija (št. EPITT 18931)
English: If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.
Slovenian: Če pljuvate ali izkašljujete kri, se takoj posvetujte z zdravnikom.
English: Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Slovenian: Bolnike je treba seznaniti s tveganjem za pljučnico in jim svetovati, da ob pojavu trdovratnega kašlja ali dispneje nemudoma obiščejo zdravnika.
English: Not known: frequency cannot be estimated from the available data Increased urine output
Slovenian: Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov Povečano izločanje urina
English: Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Slovenian: Pojavi se lahko akutna ali kronična intersticijska pljučnica, ki je pogosto povezana z eozinofilijo, poročali pa so tudi o smrtnih primerih.
English: Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting
Slovenian: Zapora črevesja - huda oblika zaprtja z dodatnimi simptomi, kot so bolečine v trebuhu, napihnjenost ali bruhanje.
English: The following side effects have also been reported: Frequency not known (cannot be estimated from the available data): bleeding from the lungs
Slovenian: Poročali so tudi o naslednjih neželenih učinkih: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): krvavitev iz pljuč
English: Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
Slovenian: Metotreksat - pljučna alveolarna krvavitev (št. EPITT 18850)
English: Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Slovenian: Bolnika je treba vprašati glede morebitnih motenj v delovanju pljuč, po potrebi se opravi tudi preiskava pljučne funkcije.
English: Frequency ‘not known': Non-mechanical intestinal obstruction
Slovenian: Neznana pogostnost: Nemehanska obstrukcija črevesja
English: Symptoms typically include dyspnoea, cough (especially a dry nonproductive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Slovenian: Značilne simptome, ki vključujejo dispnejo, kašelj (zlasti suh, neproduktiven), bolečino v prsnem košu in povišano telesno temperaturo, je treba spremljati ob vsakem nadaljnjem obisku zdravnika.
English: Thirst and increased water consumption Hypernatraemia - increased sodium in blood
Slovenian: Hipernatriemija - zvišana raven natrija v krvi
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage* *(has been reported for methotrexate used in rheumatologic and related indications)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Neznana pogostnost: epistaksa, pljučna alveolarna krvavitev* * (o tem so poročali pri uporabi metotreksata pri revmatoloških in sorodnih indikacijah)
English: Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate.
Slovenian: Pri uporabi metotreksata pri bolnikih z osnovno revmatološko boleznijo so poročali o akutni krvavitvi iz pljuč.
English: For methotrexate-containing medicinal products with both nononcologic and oncologic indications
Slovenian: Za zdravila, ki vsebujejo metotreksat, z neonkološkimi in onkološkimi indikacijami
English: For methotrexate-containing medicinal products with oncologic indications
Slovenian: Za zdravila, ki vsebujejo metotreksat, z onkološkimi indikacijami
English: Frequency ‘not known'
Slovenian: Neznana pogostnost:
English: Frequency not known (cannot be estimated from the available data): bleeding from the lungs* *(has been reported for methotrexate used in patients with underlying rheumatologic disease).
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): krvavitev iz pljuč*.
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood
Slovenian: − vnetje pljuč (simptomi se lahko kažejo kot splošno slabo počutje, suh, dražeč kašelj, zadihanost,
English: Pemetrexed - Nephrogenic diabetes insipidus (EPITT no
Slovenian: Pemetreksed - nefrogeni diabetes insipidus (št. EPITT 18930)
English: Respiratory system
Slovenian: Bolezni prebavil
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Neznana pogostnost: epistaksa, pljučna alveolarna krvavitev
English: MD: entire risk period.
Slovenian: MD: celotno obdobje tveganja.
English: SC In ovo
Slovenian: s.c. In ovo
English: The vaccine is now ready for use.
Slovenian: Cepivo je zdaj pripravljeno za uporabo.
English: The usual aseptic precautions should be applied to all preparation and administration procedures.
Slovenian: Običajni aseptični previdnostni ukrepi morajo biti uporabljeni pri vseh postopkih priprave in uporabe.
English: ATCvet code: QI01AD16.
Slovenian: Oznaka ATC vet: QI01AD16.
English: Date of first authorisation: 22/08/2017
Slovenian: Datum pridobitve dovoljenja za promet: 22/08/2017
English: Do not thaw in hot water or ice cold water.
Slovenian: Ne odmrzujte v vroči vodi ali ledeno mrzli vodi.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.
English: THE NETHERLANDS
Slovenian: NIZOZEMSKA
English: Preparation of the vaccine:
Slovenian: Priprava cepiva:
English: However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Slovenian: Vendar pa je treba upoštevati previdnostne ukrepe, da se izognemo neposrednemu ali posrednemu stiku med cepljenimi piščanci in purani.
English: Remove the syringe and invert the bag (6-8 times) to mix the vaccine.
Slovenian: Odstranite brizgo in obračajte vrečko (6-8krat), da se cepivo premeša.
English: If you notice any serious effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, celo tiste, ki še niso navedene v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo obvestite svojega veterinarja.
English: 1 PFU - plaque forming units.
Slovenian: 1 PFU: enote, ki tvorijo plak
English: It is recommended to handle a maximum of 5 ampoules (from one cane only) at a time.
Slovenian: Priporočljivo je, da delate z največ 5 ampulami (samo iz enega niza)
English: Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or 0.05 ml for in ovo use) contains:
Slovenian: Vsak odmerek rekonstituiranega cepiva (0,2 ml za subkutano uporabo ali 0,05 ml za in ovo uporabo) vsebuje:
English: Safety trials have shown that the strain is safe for turkeys.
Slovenian: Poskusi varnosti kažejo, da je sev za purane varen.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: please note; the sentence ‘for animal treatment only' will only appear in the English and will not be translated
Slovenian: Opomba; stavek ‘for animal treatment only' je samo v angleščini in se ne prevede.
English: Care should be exercised to prevent contaminating the hands, eyes and clothing with the suspension.
Slovenian: Paziti morate, da ne kontaminirate rok, oči in obleke s suspenzijo.
English: (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
Slovenian: (število odmerkov na ampulo je navedeno na barvni priponki, ki je pripeta na vsak niz ampul)
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Thaw the ampoules in clean water at 25-27 °C.
Slovenian: Ampule odmrzujte v čisti vodi pri 25-27 °C.
English: Special warnings for each target species: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto: Cepite samo zdrave živali.
English: If frozen suspension is situated in the tip of the ampoule this indicates that the suspension has been thawed and must not be used.
Slovenian: Če je v konici ampule zmrznjena suspenzija, to pomeni, da je bila suspenzija odmrznjena, in je ne smete uporabiti.
English: Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
Slovenian: Ampulo osušite, nato jo na vratu odlomite in takoj postopajte, kot je opisano spodaj.
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.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora, namenjema vzbujanju aktivne imunosti, ne spade v področje uprabe Uredbe (EC) No 470/2009.
English: Intervet International B.V. Ambachtstraat 2, 4, 5a 3732 CN De Bilt THE NETHERLANDS
Slovenian: Ambachtstraat 2, 4, 5a 3732 CN De Bilt
English: As this is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Slovenian: Ker je cepivo živo, se vakcinalni sev izloči iz cepljenih živali in se lahko razširi na purane.
English: CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes.
Slovenian: PREVIDNOST: Znano je, da ampule eksplodirajo ob nenadnih spremembah temperature.
English: Pancreatic digest of casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate Water for injections
Slovenian: saharoza pankreasni presnovek kazeina fenolsulfonftalein (rdeči fenol) kalijev dihidrogenfosfat voda za injekcije
English: The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g. during long vaccination sessions).
Slovenian: Vrečko s cepivom je treba med cepljenjem večkrat narahlo obračati, da je zagotovljeno, da suspenzija za injiciranje ostane homogena in da je apliciran pravilni titer vakcinalnega virusa (npr. med dolgimi postopki cepljenja).
English: Subcutaneous use and in ovo use.
Slovenian: Subkutana uporaba in in ovo uporaba.
English: After adding the contents of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection.
Slovenian: Ko ste vsebino ampule dodali vehiklu, je pripravek za uporabo bistra, rdeče obarvana suspenzija za injiciranje.
English: In ovo: One single injection of 0.05 ml per chicken egg.
Slovenian: In ovo: Ena injekcija 0,05 ml na kokošje jajce.
English: Number of vaccine ampoules for subcutaneous use
Slovenian: Število ampul s cepivom za subkutano uporabo
English: Gently swirl the ampoule(s) to disperse the contents.
Slovenian: Ampulo(e) narahlo vrtite, da se vsebina dispergira.