natgillin/translations-raw huggingface dataset:
Since Vectormune ND is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. 
Cepivo Vectormune ND je živo cepivo, zato se sev cepiva izloča iz cepljenih ptic in se lahko razširi na purane.
Why is Vectormune ND approved? 
Zakaj je bilo zdravilo Vectormune ND odobreno?
Vectormune ND is a veterinary vaccine used to protect chickens against Newcastle disease (ND) and Marek's disease (MD). 
Vectormune ND je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito piščancev pred atipično kokošjo kugo (boleznijo Newcastle) in Marekovo boleznijo.
The active substance in Vectormune ND is a turkey herpesvirus (rHVT/ND) that does not cause disease in chickens and has been modified so that it also produces one of the proteins of a strain of Newcastle disease virus (D-26 lentogenic strain). 
Zdravilna učinkovina v zdravilu Vectormune ND je puranji virus herpesa (rHVT/ND), ki ne povzroča bolezni pri piščancih in ki je bil spremenjen tako, da proizvaja tudi eno od beljakovin seva virusa bolezni Newcastle D 26 (lentogeni sev D-26).
MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs. 
Marekova bolezen je okužba z virusom herpesa pri piščancih, ki lahko povzroči paralizo kril in nog ter nastanek tumorjev v različnih organih.
It is not intended to provide practical advice on how to use Vectormune ND. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Birds infected with MD virus can be carriers and shedders of the virus for life. 
Ptice, okužene z virusom Marekove bolezni, so lahko prenašalke in raznašalke virusa celo življenje.
For ND protection starts at 3 weeks of age and lasts until 9 weeks of age for broilers (chickens bred for meat) and 18 weeks of age for layers (chickens bred for egg production). 
Zaščita proti atipični kokošji kugi se pri pitovnih piščancih (piščancih za vzrejo mesa) razvije pri starosti treh tednov in traja do devetih tednov starosti, pri nesnicah (piščancih za proizvodnjo jajc) pa traja do 18. tedna starosti.
Newcastle disease and Marek's disease vaccine (live recombinant) 
cepivo proti atipični kokošji kugi in Marekovi bolezni (živo, rekombinantno)
For practical information about using Vectormune ND, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Vectormune ND naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Vectormune ND, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Vectormune ND naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The modified turkey herpesvirus in Vectormune ND is closely related to MD herpesvirus and will also produce the fusion protein which forms part of the outer coat of ND virus. 
Spremenjeni puranji virus herpesa v cepivu Vectormune ND je zelo soroden virusu herpesa Marekove bolezni in bo ustvaril fuzijski protein, ki tvori del zunanje ovojnice virusa atipične kokošje kuge.
Twenty-two Vectormune ND vaccinated day-old layer chickens from this study were challenged at day 21 in the laboratory with ND strain and had no clinical signs for up to 2 weeks after challenge while all of 12 unvaccinated birds used for comparison died. 
Na 21. dan študije so v laboratoriju sevu atipične kokošje kuge izpostavili 22 en dan starih nesnic, ki so bile v okviru študije cepljene s cepivom Vectormune ND, pri čemer se pri njih klinični znaki niso pokazali še najmanj dva tedna po izpostavitvi virusu, medtem ko je vseh 12 necepljenih ptic, ki so jih uporabili kot primerjalno skupino, umrlo.
Safety information has been included in the summary of product characteristics and the package leaflet for Vectormune ND, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. 
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
This will help protect the chickens against ND and MD. 
To pomaga zaščititi piščance pred atipično kokošjo kugo in Marekovo boleznijo.
How does Vectormune ND work? 
Kako zdravilo Vectormune ND deluje?
In a third field study around 10,000 one-day-old layer chickens were vaccinated with Vectormune ND and a similar number with a vaccine against ND alone. 
V tretji terenski študiji je bilo s cepivom Vectormune ND cepljenih približno 10 000 en dan starih nesnic, podobno število pa je bilo cepljenih s cepivom samo proti atipični kokošji kugi.
How is Vectormune ND used? 
Kako se zdravilo Vectormune ND uporablja?
No signs of MDV or NDV outbreaks were detected from samples taken from both groups at days 35, 66, 102 and completion at day 118. 
Pri vzorcih, ki so jih iz obeh skupin odvzeli na 35., 66., 102. in zadnji, 118. dan študije, niso našli nobenih znakov izbruha atipične kokošje kuge ali Marekove bolezni.
For the full list of restrictions, see the package leaflet. 
Znanih neželenih učinkov cepiva Vectormune ND ni. Za celoten seznam omejitev glejte navodilo za uporabo.
Four-week-old chickens from vaccinated eggs were challenged with ND virus and 86% of the chickens were protected compared with 0-10% in the unvaccinated group. 
Štiri tedne stare piščance iz cepljenih jajc so v laboratoriju izpostavili virusu atipične kokošje kuge in ugotovili, da je bilo zaščitenih 86 % cepljenih piščancev, v necepljeni skupini pa 0-10 %.
In the second field study, a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND. 
V drugi terenski študiji so s cepivom Vectormune ND cepili skupino 18 dni starih jajc z zarodki in skupino en dan starih piščancev.
Five-week-old chickens from the vaccinated eggs were challenged with ND virus and 91% of vaccinated chickens were protected compared with no protection in the unvaccinated group. 
Pet tednov stare piščance iz cepljenih jajc so v laboratoriju izpostavili virusu atipične kokošje kuge in ugotovili, da je bilo 91 % cepljenih piščancev zaščitenih, medtem ko v necepljeni skupini zaščite ni bilo.
In the first field study a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND. 
V prvi terenski študiji so s cepivom Vectormune ND cepili skupino 18 dni starih jajc z zarodki in skupino en dan starih piščancev.
Four-week-old chickens from the group of one-day-old vaccinated chicks were challenged with ND virus and Vectormune ND provided protection in 95% of the chickens compared with 0-10% in the non-vaccinated group. 
Štiri tedne stare piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu atipične kokošje kuge, pri čemer je cepivo Vectormune ND omogočilo 95-odstotno zaščito, medtem ko je bila zaščita v necepljeni skupini od 0- do 10-odstotna.
Nineday-old broilers from the group of chicks vaccinated at one-day-old were challenged with MD virus and 82% of the chickens were protected compared with 12% in the unvaccinated group. 
Devet dni stare pitovne piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu Marekove bolezni in ugotovili, da je bilo zaščitenih 82 % cepljenih piščancev, v necepljeni skupini pa 12 %.
Nine-day-old chickens from vaccinated eggs were challenged with MD virus and 88% of the chickens were protected compared with 9-12% in the unvaccinated group. 
Devet dni stare piščance iz cepljenih jajc so v laboratoriju izpostavili virusu Marekove bolezni in ugotovili, da je bilo zaščitenih 88 % cepljenih piščancev, v necepljeni skupini pa 9-12 %.
Nine-day-old broilers from vaccinated eggs were challenged with MD virus and 85% of the chickens were protected compared with 9% in the unvaccinated group. 
Devet dni stare pitovne piščance iz cepljenih jajc so v laboratoriju izpostavili virusu Marekove bolezni in ugotovili, da je bilo zaščitenih 85 % cepljenih piščancev, v necepljeni skupini pa 9 %.
Five-week-old chickens from the vaccinated one-day-old chicks were challenged with ND virus and 81% of vaccinated chickens were protected compared with no protection in the unvaccinated group. 
Pet tednov stare piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu atipične kokošje kuge in ugotovili, da je bilo 81 % cepljenih piščancev zaščitenih, medtem ko v necepljeni skupini niso ugotovili zaščite.
Nine-dayold broilers from the chicks vaccinated at one-day-old were challenged with MD virus and Vectormune ND provided protection to 90% of the chickens compared with 9-12% in the unvaccinated group. 
Devet dni stare pitovne piščance iz skupine cepljenih, en dan starih piščancev so v laboratoriju izpostavili virusu Marekove bolezni, pri čemer je cepivo Vectormune ND omogočilo 90-odstotno zaščito, medtem ko je bila zaščita v necepljeni skupini od 9- do 12-odstotna.
Especially tell your doctor: 
Še zlasti pa povejte zdravniku:
Adopted at the 26-29 November 2018 PRAC 
Sprejeto na seji odbora PRAC, ki je potekala od 26. do 29. novembra 2018
<Product name> may need to be discontinued. 
Zdravilo <ime zdravila> bo morda treba ukiniti.
If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away. 
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, takoj obvestite zdravnika.
1 see section 4.4 
1 Glejte poglavje 4.4
Your treatment with <medicinal product> may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby. 
Zdravljenje z zdravilom <ime zdravila> bo morda treba nadaljevati med nosečnostjo, če potencialna korist prevlada nad potencialnim tveganjem za vas in vašega nerojenega otroka.
If you could get pregnant, use reliable contraception from the time you start treatment and during treatment. 
Če bi lahko zanosili, od začetka zdravljenja in med zdravljenjem uporabljajte zanesljivo kontracepcijo.
Fournier´s gangrene has to be treated immediately. 
Fournierovo gangreno je treba takoj začeti zdraviti.
Re-exposure may result in recurrence of acute pancreatitis, with decreased time to onset. 
Ponovna izpostavljenost lahko povzroči ponovitev akutnega pankreatitisa, pri čemer se čas do izbruha skrajša.
Perindopril - Raynaud's phenomenon (EPITT no 19248) 
Perindopril - Raynaudov fenomen (EPITT št. 19248)
If Fournier's gangrene is suspected, X should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted. 
Če obstaja sum na Fournierovo gangreno, je treba zdravilo X ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
What you need to know before you use Victoza In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following active substances: 
Kaj morate vedeti, preden boste uporabili zdravilo Victoza Še zlasti je pomembno, da takoj obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete zdravila, ki vsebujejo katero koli od spodaj navedenih učinkovin:
Other medicines and Trulicity 
Druga zdravila in zdravilo Trulicity
Frequency ‘not known': Raynaud's phenomenon 
Pogostnost „neznana“: Raynaudov fenomen
These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotizing fasciitis of the perineum or Fournier's gangrene which destroys the tissue under the skin. 
Ti simptomi so lahko znak redke, vendar resne ali celo življenjsko nevarne okužbe, ki se imenuje nekrotizirajoči fasciitis presredka ali Fournierova gangrena, ki uniči tkivo pod kožo.
Frequency not known (cannot be estimated from available data): Discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon). 
Neznana pogostnost (iz razpoložljivih podatkov je ni mogoče oceniti): sprememba barve, otrplost ter bolečine v prstih rok in nog (Raynaudov fenomen).
Women of childbearing potential have to use effective contraceptive measures during treatment. 
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovite kontracepcijske ukrepe.
Hyperthyroidism in pregnant women should be adequately treated to prevent serious maternal and foetal complications. 
Hipertiroidizem pri nosečnici je treba ustrezno zdraviti za preprečitev resnih zapletov pri materi in plodu.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly: 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, še zlasti:
Women of childbearing potential have to use effective contraceptive measures during treatment (see section 4.4). 
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovite kontracepcijske ukrepe (glejte poglavje 4.4).
Other medicines and Bydureon 
Druga zdravila in zdravilo Bydureon
What you need to know before you take X 
Kaj morate vedeti, preden boste vzeli zdravilo X
<Medicinal product> can cause harm to an unborn baby. 
Zdravilo <ime zdravila> lahko škoduje nerojenemu otroku.
Thiamazole is able to cross the human placenta. 
Tiamazol lahko prehaja skozi človeško placento.
Carbimazole is able to cross the human placenta. 
Karbimazol lahko prehaja skozi človeško placento.
Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes) with frequency ‘rare' 
Lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah) s pogostnostjo „redki“.
Carbimazole; thiamazole - New information on the known risk of birth defects and neonatal disorders in case of exposure during pregnancy (EPITT no 19238) 
Karbimazol; tiamazol - Nove informacije o znanem tveganju za prirojene napake in razvojne nepravilnosti pri izpostavljenosti med nosečnostjo (EPITT št. 19238)
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicine. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The use of carbimazole in pregnant women must be based on the individual benefit/risk assessment. 
Uporaba karbimazola pri nosečnici mora temeljiti na individualni oceni koristi in tveganja.
Women of childbearing potential and pregnancy 
Ženske v rodni dobi in nosečnost
In patients with diabetes mellitus Saxenda must not be used as a substitute for insulin. 
Pri bolnikih s sladkorno boleznijo se zdravilo Saxenda ne sme uporabljati kot nadomestilo za insulin.
In case of acute pancreatitis, thiamazole should be discontinued immediately. 
Pri akutnem pankreatitisu je treba tiamazol takoj ukiniti.
The use of Trulicity does not require blood glucose self-monitoring. 
Uporaba zdravila Trulicity ne zahteva samokontrole glukoze v krvi.
The use of thiamazole in pregnant women must be based on the individual benefit/risk assessment. 
Uporaba tiamazola pri nosečnici mora temeljiti na individualni oceni koristi in tveganja.
Frequency ‘not known': Acute pancreatitis 
Pogostnost „neznana“: akutni pankreatitis
Undesirable effects Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency ‘rare': Lichenoid reactions 
Preglednica neželenih učinkov Bolezni kože in podkožja Pogostnost „redki“: lihenoidne reakcije.
In case of acute pancreatitis, carbimazole should be discontinued immediately. 
Pri akutnem pankreatitisu je treba karbimazol takoj ukiniti.
Based on human experience from epidemiological studies and spontaneous reporting, carbimazole is suspected to cause congenital malformations when administered during pregnancy, particularly in the first trimester of pregnancy and at high doses. 
Na podlagi izkušenj pri ljudeh iz epidemioloških študij in spontanega poročanja obstaja sum, da karbimazol povzroča kongenitalne malformacije, če se daje med nosečnostjo, zlasti v prvem trimesečju nosečnosti in pri velikih odmerkih.
However, if you are also using a sulphonylurea or an insulin your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea or insulin. 
Vendar, če uporabljate tudi sulfonilsečnino ali insulin, vam bo zdravnik morda priporočal, da preverjate ravni sladkorja v krvi za prilagoditev odmerka sulfonilsečnine ali insulina.
Certolizumab pegol; etanercept; golimumab; infliximabLichenoid skin reactions (EPITT no 19128) 
Certolizumab pegol; etanercept; golimumab; infliksimablihenoidna reakcija kože (EPITT št. 19128)
Warnings and precautions …Tell your doctor straight away if you develop fever or abdominal pain, which may be signs of inflammation of the pancreas (acute pancreatitis). 
Opozorila in previdnostni ukrepi … Takoj obvestite zdravnika, če se vam pojavi povišana telesna temperatura ali bolečine v trebuhu, kar so lahko znaki vnetja trebušne slinavke (akutnega pankreatitisa).
Reported malformations include aplasia cutis congenita, craniofacial malformations (choanal atresia; facial dysmorphism), exomphalos, oesophageal atresia, omphalo-mesenteric duct anomaly, and ventricular septal defect. 
Malformacije, o katerih so poročali, vključujejo kongenitalno aplazijo kože, kraniofacialne malformacije (hoanalno atrezijo; obrazni dismorfizem), eksomfalos, ezofagealno atrezijo, nepravilnost omfalomezenteričnega kanala in defekt ventrikularnega septuma.
Based on human experience from epidemiological studies and spontaneous reporting, thiamazole is suspected to cause congenital malformations when administered during pregnancy, particularly in the first trimester of pregnancy and at high doses. 
Na podlagi izkušenj pri ljudeh iz epidemioloških študij in spontanega poročanja obstaja sum, da tiamazol povzroča kongenitalne malformacije, če se daje med nosečnostjo, zlasti v prvem trimesečju nosečnosti in pri velikih odmerkih.
You will not need to test your sugar levels on a day-by-day basis to set the dose of Byetta. 
Za nastavitev ustreznega odmerka zdravila Byetta vam ne bo treba dnevno preverjati ravni sladkorja.
Carbimazole; thiamazole - Pancreatitis (EPITT no 19274) 
Karbimazol; tiamazol - Pankreatitis (EPITT št. 19274)
Dulaglutide; exenatide; liraglutide - Diabetic ketoacidosis (EPITT no 19237) 
Dulaglutid; eksenatid; liraglutid - diabetična ketoacidoza (EPITT št. 19237)
Necrotising fasciitis of the perineum (Fournier´s Gangrene)1 Frequency: not known 
Infekcijske in parazitske bolezni Nekrotizirajoči fasciitis presredka (Fournierova gangrena)1 Pogostnost: neznana
The use of prolonged-release exenatide does not require additional self-monitoring. 
Uporaba eksenatida v obliki s podaljšanim sproščanjem ne zahteva dodatnega bolnikovega samonadzora.
When initiating Saxenda, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia. 
Ob uvedbi zdravila Saxenda je treba razmisliti o zmanjšanju odmerka sočasno uporabljanega insulina ali sekretagogov insulina (npr. sulfonilsečnine), da bi zmanjšali tveganje za hipoglikemijo.
Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors. 
Po začetku trženja so poročali o primerih nekrotizirajočega fasciitisa presredka (znan tudi kot Fournierova gangrena) pri bolnikih in bolnicah, ki so jemali zaviralce SGLT2.
Necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus. 
Nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom.
Self-monitoring may be necessary to adjust the dose of sulphonylurea or insulin. 
Samokontrola je morda potrebna za prilagajanje odmerka sulfonilsečnine ali insulina.
Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis. 
Zavedajte se, da se pred nekrotizirajočim fasciitisom lahko pojavi urogenitalna infekcija ali perinealni absces.
What you need to know before you take <medicinal product> Do not take <medicinal product> …if you had inflammation of the pancreas (acute pancreatitis) after administration of carbimazole or thiamazole in the past. 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Ne jemljite zdravila <ime zdravila> … če ste imeli v preteklosti vnetje trebušne slinavke (akutni pankreatitis) po dajanju karbimazola ali tiamazola.
What you need to know before you take <medicinal product> Do not take <medicinal product> …if you had inflammation of the pancreas (acute pancreatitis) after administration of thiamazole or carbimazole in the past… 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Ne jemljite zdravila <ime zdravila> … če ste imeli v preteklosti vnetje trebušne slinavke (akutni pankreatitis) po dajanju tiamazola ali karbimazola …
If carbimazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended (see section 4.4). 
Če se karbimazol uporablja med nosečnostjo, je upravičeno skrbno spremljanje matere, ploda in novorojenčka (glejte poglavje 4.4).
What you need to know before you use Bydureon Warnings and precautions 
Kaj morate vedeti, preden boste uporabili zdravilo Bydureon Opozorila in previdnostni ukrepi
What you need to know before you use Byetta Warnings and precautions 
Kaj morate vedeti, preden boste uporabili zdravilo Byetta Opozorila in previdnostni ukrepi
If thiamazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended (see section 4.4). 
Če se tiamazol uporablja med nosečnostjo, je upravičeno skrbno spremljanje matere, ploda in novorojenčka (glejte poglavje 4.4).
Undesirable effects Infections and infestations 
Preglednica neželenih učinkov Žilne bolezni
Dulaglutide is not a substitute for insulin. 
Dulaglutid ni nadomestilo za insulin.
However, when initiating treatment with Victoza in combination with a sulfonylurea or insulin, blood glucose selfmonitoring may become necessary to adjust the dose of the sulfonylurea or the insulin. 
Vendar bodo bolniki na začetku zdravljenja z zdravilom Victoza v kombinaciji s sulfonilsečnino ali z insulinom morda morali izvajati samokontrolo glukoze v krvi, da bo mogoče prilagoditi odmerek sulfonilsečnine ali insulina.
What you need to know before you use Trulicity Warnings and precautions 
Kaj morate vedeti, preden boste uporabili zdravilo Trulicity Opozorila in previdnostni ukrepi
- if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). 
- če uporabljate insulin; zdravnik vam bo povedal, kako zmanjšate odmerek insulina, in vam priporočil pogostejše spremljanje sladkorja v krvi, da s tem preprečite pojav hiperglikemije (visoka raven sladkorja v krvi) in diabetične ketoacidoze (zaplet pri sladkorni bolezni, ki nastopi, ko telo zaradi pomanjkanja insulina ni sposobno razgraditi glukoze).
Canagliflozin; dapagliflozin; empagliflozin; ertugliflozinFournier's gangrene (EPITT no 19308) 
Kanagliflozin; dapagliflozin; empagliflozin; ertugliflozinFournierova gangrena (EPITT št. 19308)