natgillin/translations-raw huggingface dataset:
It is recommended that animals are treated in the early stages of respiratory disease and that their response is evaluated within 48 hours.
Priporoča se zdravljenje živali v zgodnjih stadijih dihalnih obolenj, njihov odziv na zdravljenje pa se oceni v 48 urah.
This is a summary of the European Public Assessment Report (EPAR) for Draxxin.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Draxxin.
The European Commission granted a marketing authorisation valid throughout the EU for Draxxin on 23 July 2003.
Evropska komisija je dovoljenje za promet z zdravilom Draxxin, veljavno po vsej Evropski uniji, izdala 23. julija 2003.
The main measure of effectiveness was the change in symptoms over 10 days.
Glavno merilo učinkovitosti je bila sprememba simptomov v desetih dneh.
This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
To pomeni, da antibiotik morda nima več učinka na bakterije, s katerimi so okužene živali ali ljudje.
It works by attaching to the RNA (the molecules that instruct the cell how to make proteins) within the bacterial cells.
Deluje s pripojitvijo na RNK (molekule, ki celici dajejo navodila, kako tvoriti beljakovine) v celicah bakterij.
The full EPAR for Draxxin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Draxxin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
If symptoms persist, get worse or come back, treatment should be changed to another antibiotic.
Če simptomi ne pojenjajo, se okrepijo ali se ponovno pojavijo, je treba preiti na zdravljenje z drugim antibiotikom.
The main measure of effectiveness was the change in symptoms, including body temperature, breathing and recovery over a period of between two weeks and two months.
Glavno merilo učinkovitosti je bila sprememba jakosti simptomov, vključno s telesno temperaturo, dihanjem in okrevanjem v obdobju od dveh tednov do dveh mesecev.
This means to treat at the same time both diseased animals and those clinically healthy animals in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
To pomeni hkratno zdravljenje obolelih živali in klinično zdravih živali, ki so v tesnem stiku z njimi, za preprečitev razvoja kliničnih znakov pri njih in nadaljnjega širjenja bolezni.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Draxxin's benefits are greater than its risks and recommended that it be approved in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Draxxin večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Draxxin:
Druge informacije o zdravilu Draxxin:
This has not been seen in pigs and sheep after intramuscular injection.
Tega niso opazili pri prašičih in ovcah po injiciranju zdravila v mišico.
The main measure of effectiveness was the proportion of cattle whose disease was cured after three weeks.
Glavno merilo učinkovitosti je bil delež goveda, ki je bilo po treh tednih ozdravljeno.
However, some bacteria can develop resistance against tulathromycin, which will reduce its effectiveness.
Kljub temu se lahko pri nekaterih bakterijah razvije odpornost proti tulatromicinu, kar zmanjša njegovo učinkovitost.
Two weeks after treatment 84% of Draxxin-treated sheep were successfully treated compared to 82% of tilmicosin-treated sheep.
Dva tedna po zdravljenju je bilo uspešno ozdravljenih 84 % ovac, zdravljenih z zdravilom Draxxin, v primerjavi z 82 % ovac, ki so prejemale tilmikozin.
However, the third study found no difference between the effectiveness of Draxxin, oxytetracycline and placebo.
Vendar pa v tretji študiji niso ugotovili nobene razlike med učinkovitostjo zdravila Draxxin, oksitetraciklina in placeba.
The medicine should only be used for metaphylaxis in cattle and pigs once the presence of the disease in the herd has been established, and if animals are expected to develop the disease within two to three days.
Zdravilo se lahko za metafilakso pri govedu in prašičih uporablja šele potem, ko je bila v čredi ugotovljena prisotnost bolezni in če se pričakuje, da se bo pri njih v dveh do treh dneh razvila bolezen.
It should also not be used at the same time as other macrolide antibiotics or lincosamides (another type of antibiotic medicine).
Prav tako se ne sme uporabljati sočasno z drugimi makrolidnimi antibiotiki ali linkozamidi (drugo vrsto antibiotičnega zdravila).
This prevents the bacteria being able to make vital proteins and stops them growing and multiplying.
To bakterijam preprečuje, da bi lahko tvorile življenjsko pomembne beljakovine ter zaustavi njihovo rast in razmnoževanje.
Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
S pridobitvijo odpornosti proti antibiotikom dobijo bakterije sposobnost za rast kljub prisotnosti antibiotika, ki bi jih sicer običajno uničil ali omejil njihovo rast.
For cattle the meat withdrawal period is 22 days, for pigs it is 13 days and for sheep it is 16 days.
Karenca za goveje meso je 22 dni, za prašičje 13 dni in jagnjetino 16 dni.
In all studies, Draxxin was at least as effective as the comparator medicines.
V vseh študijah je bilo zdravilo Draxxin vsaj tako učinkovito kot primerjalna zdravila.
Looking at the studies taken together, it was more effective than placebo.
Ob presoji vseh študij skupaj je bilo učinkovitejše od placeba.
For the best results sheep with foot rot should be kept in a dry environment.
Za dosego boljših rezultatov je treba ovce z nalezljivo šepavostjo držati v suhem okolju.
The main measure of effectiveness was the proportion of pigs that completed the full three or six weeks of each study without needing to be removed from the study because of SRD.
Glavno merilo učinkovitosti je bil delež prašičev, ki so bili v študijo vključeni celotno obdobje treh ali šestih tednov trajanja posamezne študije, ne da bi jih bilo treba izločiti iz nje zaradi dihalnega obolenja.
Draxxin is available as a solution for injection (25 mg/ml and 100 mg/ml).
Zdravilo Draxxin je na voljo v obliki raztopine za injiciranje (25 mg/ml in 100 mg/ml).
• Early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires systemic treatment (treatment with a medicine given by mouth or by injection).
• zgodnjih stadijev nalezljive šepavosti ovac, ki jo povzroča bakterija Dichelobacter nodosus in ki zahteva sistemsko zdravljenje (zdravljenje z zdravili, ki se dajejo peroralno ali z injiciranjem).
What is Draxxin and what is it used for?
Kaj je zdravilo Draxxin in za kaj se uporablja?
Why is Draxxin approved?
Zakaj je bilo zdravilo Draxxin odobreno?
The most common side effects with Draxxin in sheep (which may affect more than 1 in 10 sheep) are short lived signs of discomfort (head shaking, rubbing the injection site and backing away) lasting only a few minutes.
Najpogostejši neželeni učinki zdravila Draxxin pri ovcah (ki lahko prizadanejo več kot eno ovco od 10) so kratkotrajni znaki nelagodja (stresanje z glavo, drgnjenje na mestu injiciranja in izmikanje), ki trajajo samo nekaj minut.
What are the risks associated with Draxxin?
Kakšna tveganja so povezana z zdravilom Draxxin?
Draxxin is used to treat the following diseases if they are caused by bacteria that are sensitive to tulathromycin:
Uporablja se za zdravljenje naslednjih bolezni, če jih povzročajo bakterije, ki so občutljive za tulatromicin:
What benefits of Draxxin have been shown in studies?
Kakšne koristi je zdravilo Draxxin izkazalo v študijah?
Draxxin is given as a single injection of 2.5 mg per kilogram bodyweight.
Zdravilo Draxxin se daje kot enkratna injekcija v odmerku 2,5 mg na kilogram telesne mase.
It is also the time required after administration of a medicine before milk can be used for human consumption.
Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
In the treatment studies, the cattle were infected with BRD-causing bacteria, but the cattle in the prevention studies had no symptoms of the disease.
V študijah zdravljenja bolezni so bile živali okužene z bakterijami, ki povzročajo dihalna obolenja goveda, živali, vključene v študije preprečevanja bolezni, pa niso imele nobenih simptomov bolezni.
A single 2.5 mg/kg dose of Draxxin was effective in treating and preventing further outbreak of BRD in cattle and SRD in pigs.
Enkratni odmerek v višini 2,5 mg/kg zdravila Draxxin je bil učinkovit pri zdravljenju in preprečevanju nadaljnjega izbruha dihalnih obolenj pri govedu in prašičih.
In sheep, Draxxin is injected into the neck muscle.
Pri ovcah se zdravilo Draxxin injicira v vratno mišico.
Draxxin should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics.
Zdravilo Draxxin se ne sme uporabljati pri živalih, ki so preobčutljive za (alergične na) makrolidne antibiotike.
Draxxin may also cause sensitisation (redness, itching and swelling) if it comes into contact with the skin.
Zdravilo Draxxin lahko povzroči tudi senzibilizacijo (rdečico, srbenje in oteklino), če pride v stik s kožo.
Draxxin must not be used in animals that are producing milk for human consumption, or in pregnant animals intended to produce milk for human consumption within two months of their expected date of giving birth.
Zdravilo Draxxin se ne sme uporabljati pri živalih, katerega mleko je namenjeno prehrani ljudi, in brejih živalih, katerih mleko je namenjeno prehrani ljudi, v dveh mesecih pred pričakovano kotitvijo.
The 25 mg/ml solution for injection is for pigs only whilst the 100 mg/ml solution for injection is for cattle, pigs and sheep.
Raztopina za injiciranje z jakostjo 25 mg/ml se uporablja samo pri prašičih, raztopina za injiciranje z jakostjo 100 mg/ml pa je namenjena za uporabo pri govedu, prašičih in ovcah.
• infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
• infekcioznega govejega keratokonjuktivitisa (IBK), tj. obolenja oči, ki ga povzroča bakterija Moraxella bovis;
For effectiveness in treating foot rot in sheep, Draxxin was compared to tilmicosin in a study involving 477 sheep with typical signs of foot rot (foul smell, damaged tissue between the claws of at least one foot and lameness).
Za ugotavljanje učinkovitosti zdravila Draxxin pri nalezljivi šepavosti ovac so ga s tilmikozinom primerjali v eni študiji, v katero je bilo vključenih 477 ovac z značilnimi znaki šepavosti (smrad, poškodovano tkivo med parklji na vsaj eni nogi ter šepanje).
Other types of reaction to the injection persist for about 30 days after injection in cattle and pigs.
Druge vrste reakcij na injiciranje so pri govedu in prašičih prisotne približno 30 dni po injiciranju zdravila.
• bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
• dihalnih obolenj goveda (BRD), ki jih povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida, Histophilus somni in Mycoplasma bovis;
How does Draxxin work?
Kako zdravilo Draxxin deluje?
The main measure of effectiveness was clinical cure rate (no SRD or mild SRD) on day 14.
Glavno merilo učinkovitosti je bila stopnja klinične ozdravitve (brez dihalnega obolenja prašičev ali z milejšo obliko tega obolenja) na 14. dan.
Draxxin was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment).
Zdravilo Draxxin so primerjali s tilmikozinom ali florfenikolom (drugima antibiotikoma), v študijah preprečevanja bolezni pa tudi s placebom (zdravilom brez zdravilne učinkovine).
For practical information about using Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Draxxin naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Draxxin naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site.
Pri govedu se injicira pod kožo, če žival tehta več kot 300 kg, pa je treba odmerek razdeliti tako, da se na enem mestu ne injicira več kot 7,5 ml zdravila.
Draxxin can cause eye irritation.
Zdravilo Draxxin lahko povzroči draženje oči.
If accidental skin exposure occurs, the skin should be washed immediately with soap and water.
Pri nenamernem stiku kože z zdravilom je treba kožo nemudoma sprati z milom in vodo.
The active substance in Draxxin, tulathromycin, is an antibiotic that belongs to the class ‘macrolides'.
Zdravilna učinkovina v zdravilu Draxxin, tulatromicin, je antibiotik, ki spada v skupino „makrolidov“.
In two studies, it was compared with placebo, and the third study also compared it with oxytetracycline (another antibiotic).
V dveh študijah so ga primerjali z učinkovitostjo placeba, v tretji pa tudi z oksitetraciklinom (drugim antibiotikom).
Draxxin was as effective as tilmicosin in treating the early stages of severe foot rot.
Zdravilo Draxxin je bilo pri zdravljenju zgodnjih stadijev hude šepavosti enako učinkovito kot tilmikozin.
The effectiveness of Draxxin in treating SRD has been studied in pigs in two main studies, where it was compared with the antibiotics tiamulin or florfenicol.
Učinkovitost zdravila Draxxin pri zdravljenju dihalnih obolenj prašičev so raziskovali v dveh glavnih študijah, v katerih so ga primerjali z antibiotikoma tiamulinom ali florfenikolom.
In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site.
Pri prašičih se injicira v mišico, če žival tehta več kot 80 kg, pa je treba odmerek razdeliti tako, da se na enem mestu ne injicira več kot 2 ml zdravila.
In case of accidental selfinjection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali ovojnino.
In two of the three studies of IBK, Draxxin was more effective than placebo in curing the disease.
V dveh od treh študij infekcioznega govejega keratokonjuktivitisa je bilo zdravilo Draxxin pri ozdravljenju bolezni učinkovitejše od placeba.
Draxxin is an antibiotic medicine that contains the active substance tulathromycin.
Zdravilo Draxxin je zdravilo z antibiotičnim delovanjem, ki vsebuje zdravilno učinkovino tulatromicin.
The effectiveness of Draxxin in treating or preventing BRD was studied in nine main studies involving calves, carried out during an outbreak of the disease.
Učinkovitost zdravila Draxxin pri zdravljenju ali preprečevanju dihalnih obolenj goveda so raziskovali v devetih glavnih študijah, v katere so bila vključena teleta, izvedene pa so bile med izbruhom bolezni.
Treatment with Draxxin was compared to another antibiotic, tildipirosin.
Zdravljenje z zdravilom Draxxin so primerjali s tildipirozinom (drugim antibiotikom).
For the metaphylaxis of SRD, the effectiveness of Draxxin was studied in six main studies, in which it was compared with placebo.
Pri metafilaksi dihalnih obolenj prašičev so učinkovitost zdravila Draxxin raziskovali v šestih glavnih študijah, v katerih so ga primerjali s placebom.
If Draxxin accidentally gets into the eyes, they should be flushed immediately with clean water.
V primeru nenamernega stika zdravila z očmi jih je treba nemudoma sprati s čisto vodo.
Temporary pain and swelling at the injection site in cattle can last up to 30 days after subcutaneous injection.
Podkožno injiciranje zdravila lahko pri govedu povzroči trenutno bolečino in lokalno oteklino na mestu injiciranja, ki lahko traja do 30 dni.
Draxxin is effective against the bacteria that most commonly cause BRD, SRD, IBK and foot rot.
Zdravilo Draxxin je učinkovito proti bakterijam, ki najpogosteje povzročajo dihalna obolenja goveda, dihalna obolenja prašičev, infekciozni goveji keratokonjuktivitis in šepavost ovac.
Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica.
• dihalnih obolenj prašičev (SRD), ki jih povzročajo bakterije Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae Haemophilus parasuis ali Bordetella bronchiseptica;
Draxxin can also be used for metaphylaxis of BRD and SRD.
Zdravilo Draxxin se lahko uporablja tudi za metafilakso dihalnih obolenj goveda in dihalnih obolenj prašičev.
For the treatment of IBK, the effectiveness of Draxxin has been studied in three main studies involving calves.
Pri zdravljenju infekcioznega govejega keratokonjuktivitisa so učinkovitost zdravila Draxxin raziskovali v treh glavnih študijah, v katere so bila vključena teleta.
SRD with Bordetella bronchiseptica present.
V tretjo študijo so bili vključeni prašiči z dihalnim obolenjem in prisotnostjo bakterije Bordetella bronchiseptica.
These include the following:
Ukrepi vključujejo naslednje:
15 March 2013
15. marec 2013
The European Commission issued a decision on 15 March 2013.
Evropska komisija je sklep izdala dne 15. marca 2013.
1 For information on the outcome of this review, see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
1 Za informacije o izsledkih tega pregleda glejte spletno stran: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
What are the recommendations for surgeons?
Kakšna so priporočila za kirurge?
varied, suspended or withdrawn across the EU.
ohrani ali pa ga je treba spremeniti, začasno umakniti oziroma preklicati.
Why were fibrin sealants reviewed?
Zakaj so bila fibrinska lepila ponovno preučena?
Several fibrin sealants have been authorised in European Union (EU) Member States through national procedures.
V državah članicah EU je bilo z nacionalnimi postopki odobrenih več fibrinskih lepil.
At the same time, the United Kingdom medicines agency requested a similar assessment for Quixil and for the other fibrin sealants authorised in EU countries, given that the risk of air embolism could not be excluded for these products.
Istočasno je agencija Združenega kraljestva za zdravila zaprosila za podobno oceno zdravila Quixil in drugih fibrinskih lepil, odobrenih v državah EU, glede na to, da tveganja za zračno embolijo pri teh izdelkih ni mogoče izvzeti.
A group of experts in blood products, haemostasis (the stopping of bleeding) and surgery was also consulted.
Posvetoval se je tudi s skupino strokovnjakov za krvne proizvode, hemostazo (ustavljanje krvavenja) in kirurgijo.
What are fibrin sealants?
Kaj so fibrinska lepila?
• the wording of the product information should be strengthened and educational materials updated to provide clear and consistent information to surgeons on the recommended pressure and distance during spray application;
• okrepiti je treba besedilo informacij o zdravilu in posodobiti izobraževalno gradivo, da se kirurgom zagotovijo jasne in dosledne informacije o priporočenem tlaku in razdalji med pršenjem;
When the two solutions are mixed together, thrombin breaks fibrinogen up into smaller units called fibrin.
Če raztopini pomešamo, trombin povzroči razpad fibrinogena v manjše enote, ki jih imenujemo fibrini.
Due to the close similarity of Evicel and Quixil, the CHMP concluded its review of Evicel and Quixil in November 20121.
Zaradi velike podobnosti zdravil Evicel in Quixil je odbor CHMP pregled teh zdravil zaključil novembra 20121.
In particular, when spraying these products: the recommended pressures should not be exceeded, and the sealant should not be sprayed at a closer distance than recommended; patients should be closely monitored for signs of possible gas embolism (by measuring blood pressure, pulse rate, and oxygen and CO2 levels in the blood).
Pri pršenju teh zdravil je treba upoštevati zlasti naslednje: ne presezite priporočenega tlaka in lepila ne pršite na manjši razdalji od priporočene; bolnike je treba natančno spremljati za znake morebitne plinske embolije (z merjenjem krvnega tlaka, srčnega utripa ter koncentracij kisika in CO2 v krvi).
The Committee also agreed that the company marketing Tisseel, Tissucol and Artiss should provide a letter to relevant healthcare professionals in the EU including important information on the safe use of these medicines.
Odbor se je prav tako strinjal, da morajo podjetja, ki imajo dovoljenje za promet z zdravili Tisseel, Tissucol in Artiss, zadevnim zdravnikom v EU poslati dopis s pomembnimi informacijami o varni uporabi teh zdravil.
Beriplast P does not require a gas-assisted spray device.
Zdravilo Beriplast P ne zahteva uporabe pripomočka za plinsko pršenje.
For Evicel, Quixil, Tisseel, Tissucol and Artiss, the solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
Trenutno se zdravila Evicel, Quixil, Tisseel, Tissucol in Artiss pršijo z uporabo zraka pod tlakom ali ogljikovega dioksida (CO2).
Following cases of gas embolism (presence of a gas bubble in the blood that affects the blood flow) reported in association with the use of Evicel and Quixil, in May 2012 the European Commission asked the CHMP to issue an opinion on whether the marketing authorisation for Evicel should be maintained,
Evropska komisija je po primerih plinske embolije (prisotnost zračnega mehurčka v krvi, ki vpliva na krvni obtok), o katerih so poročali v povezavi z uporabo zdravil Evicel in Quixil, maja 2012 pozvala CHMP, naj predloži svoje mnenje o tem, ali se lahko dovoljenje za promet za zdravilo Evicel v EU
• the product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of possible gas embolism.
• informacije o zdravilu morajo vključevati opozorilo, da je tveganje za plinsko embolijo večje pri pršenju fibrinskih lepil z zrakom kot pri pršenju s CO2, in da je treba bolnike natančno spremljati za znake morebitne plinske embolije.
• the company for Tisseel, Tissucol and Artiss should ensure that these products are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and which have labels stating the recommended pressure and distance;
• podjetje za zdravila Tisseel, Tissucol in Artiss mora zagotoviti, da se zdravila uporabljajo z regulatorji tlaka, ki ne presegajo največjega tlaka, dovoljenega za nanos fibrinskih lepil, in da sta na nalepkah izdelkov navedena priporočeni tlak in priporočena razdalja;
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines continue to outweigh their risks, but that appropriate measures have to be put in place to optimise the safe use of these medicines when they are applied as a spray during surgery.
Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je sklenil, da koristi teh zdravil še zmeraj odtehtajo z njimi povezana tveganja, vendar je treba sprejeti ustrezne ukrepe za optimizacijo njihove varne uporabe pri nanosu s pršenjem med kirurškim posegom.
Fibrin sealants are medicines that are used as a sealant (glue) during surgery to help reduce local bleeding.
Fibrinska lepila so zdravila, ki se med kirurškimi posegi uporabljajo kot tesnila (lepila) v pomoč pri zmanjšanju lokaliziranega krvavenja.