natgillin/translations-raw huggingface dataset:
In some dogs and cats, there may be a decrease in breathing rate and the mucous membranes may appear pale or with a blue tinge.
Pri nekaterih psih in mačkah se lahko zmanjša hitrost dihanja, sluznična membrana pa je lahko videti bleda ali modrikasta.
• For deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
• za globoko sedacijo in analgezijo pri psih ob sočasni uporabi z butorfanolom (sedativom in analgetikom) za postopke, ki vključujejo manjše kirurške posege.
• When carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia).
• kadar se izvajajo blago do zmerno boleči postopki in pregledi, pri katerih mora biti žival ukročena ali mirna ter manj občutljiva na bolečino (analgezija).
Dexdomitor causes a decrease in heart rate and body temperature.
Zdravilo Dexdomitor povzroči upočasnitev bitja srca in zmanjšanje telesne temperature.
The CVMP concluded that the benefits of Dexdomitor exceed the risks and recommended that it be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Dexdomitor večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
When used in cats, ketamine should be used as the anaesthetic agent.
Kadar se uporablja pri mačkah, je treba kot anestetično sredstvo uporabiti ketamin;
Information on the prescription status of this product may be found on the label/outer package.
Podatki o predpisovanju zdravila so navedeni na nalepki/zunanji ovojnini.
Other side effects can occur when Dexdomitor is used with other medicines.
Drugi neželeni učinki se lahko pojavijo, če se zdravilo Dexdomitor uporablja sočasno z drugimi zdravili.
Dexdomitor is used to sedate (calm down) dogs and cats in the following situations:
Zdravilo Dexdomitor se uporablja za sedacijo (pomiritev) psov in mačk v naslednjih primerih:
It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.
Zdravilo se ne sme uporabljati pri živalih, ki imajo težave s srcem ali ožiljem, imajo resno sistemsko bolezen (vključuje celo telo), so moribundne (tik pred poginom) ali so ugotovljeno preobčutljive za (alergične na) deksmedetomidin ali katero koli drugo sestavino zdravila.
What is the risk associated with Dexdomitor?
Kakšna tveganja so povezana z zdravilom Dexdomitor?
People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.
Osebe z znano preobčutljivostjo na deksmedetomidin ali katero koli drugo sestavino zdravila morajo zdravilo dajati previdno.
The dose depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats.
Odmerek je pri psih odvisen od telesne površine (izračuna se s pomočjo telesne mase), pri mačkah pa od telesne mase.
Why has Dexdomitor been approved?
Zakaj je bilo zdravilo Dexdomitor odobreno?
Dexdomitor was investigated in studies involving dogs and cats in which its effectiveness was compared with that of medetomidine.
Zdravilo Dexdomitor so proučevali v študijah pri psih in mačkah, v katerih so njegovo učinkovitost primerjali z učinkovitostjo medetomidina.
If Dexdomitor is accidentally self-injected or taken by mouth, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Če se zdravilo Dexdomitor nenamerno injicira ali nenamerno zaužije, je treba nemudoma poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
Contact with the skin, eyes of mucous (moist body surfaces) should be avoided.
Izogibati se je treba tudi stiku zdravila s kožo, očmi ali sluznico (vlažnimi površinami telesa).
Dexdomitor also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and for premedication in dogs and cats before induction of general anaesthesia, reducing the amount of anaesthetic that the dogs and cats require.
Zdravilo Dexdomitor je pokazalo primerno učinkovitost tudi pri globoki sedaciji psov ob sočasni uporabi z butorfanolom in kot priprava na poseg pri psih in mačkah pred uvajanjem splošne anestezije, pri čemer je zmanjšalo količino anestetika, ki so ga psi in mačke potrebovali.
In cats, it is given by intramuscular injection.
Mačkam se zdravilo daje z intramuskularno injekcijo.
Dexdomitor contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
Zdravilo Dexdomitor vsebuje zdravilno učinkovino deksmedetomidin, ki spada v razred zdravil s psiholeptičnimi (pomirjevalnimi) učinki.
The studies showed that Dexdomitor had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats.
Študije so pokazale, da je imelo zdravilo Dexdomitor enakovreden učinek kot medetomidin pri sedaciji in analgeziji psov in mačk.
Finally, it was studied as a premedication in dogs and cats prior to induction of general anaesthesia.
Nenazadnje so zdravilo proučevali tudi kot pripravo na poseg pri psih in mačkah pred uvajanjem splošne anestezije.
In dogs, Dexdomitor is given by intravenous or intramuscular injection.
Psom se zdravilo Dexdomitor daje z intravensko ali intramuskularno injekcijo.
In dogs, both intravenous and intramuscular injections of Dexdomitor were studied.
Pri psih so proučevali tako intravenske kot intramuskularne injekcije zdravila Dexdomitor.
What is Dexdomitor used for?
Za kaj se zdravilo Dexdomitor uporablja?
Dexdomitor was also compared with medetomidne for premedication (sedation prior to anaesthesia) in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol.
Zdravilo Dexdomitor so primerjali z medetomidinom kot pripravo na poseg pri mačkah (sedacijo pred anestezijo) pred uvajanjem splošne anestezije s ketaminom in za globoko sedacijo psov pri sočasni uporabi butorfanola.
How does Dexdomitor work?
Kako zdravilo Dexdomitor deluje?
For a full list of all side effects reported with Dexdomitor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dexdomitor, glejte navodilo za uporabo.
How has Dexdomitor been studied?
Kako je bilo zdravilo Dexdomitor raziskano?
The dose is chosen according to the species being treated, the use, whether it is given by intravenous (into a vein) or intramuscular (into a muscle) injection and any other medicines that are also being used.
Odmerek je treba izbrati glede na vrsto živali, ki se zdravi, glede na namen dajanja zdravila, glede na to, ali se zdravilo vbrizga v veno ali mišico, in glede na druga sočasno uporabljana zdravila.
Dexdomitor was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine.
Zdravilo Dexdomitor je bilo pri vzpostavljanju stanja splošne anestezije pri mačkah ob sočasni uporabi ketamina vsaj tako učinkovito kot medetomidin.
Muscle tremors (shaking) and corneal opacities (cloudy spots in the cornea, the clear part of the eye in front of the pupil) may occur during sedation.
Med sedacijo se lahko pojavi drgetanje mišic, roženica pa lahko postane motna (motna mesta v prozornem delu očesa pred zenico).
What is Dexdomitor?
Kaj je zdravilo Dexdomitor?
60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups
60 vrečic + dve 1-ml brizgi + dve 3-ml brizgi + dve 10-ml brizgi + 2 posodici za mešanje
Granules for oral suspension sachet (PET/Alu/LLDPE)
100 mg zrnca za peroralno suspenzijo peroralna uporaba vrečica (PET/Alu/LLDPE)
21 March 2014 EMA/167920/2014 EMEA/H/C/002670
21. marec 2014 EMA/167920/2014 EMEA/H/C/002670
In addition, there were still outstanding problems related to quality control during its manufacture.
Poleg tega je bilo še vedno nekaj nerešenih težav, povezanih z nadzorom kakovosti pri njegovi izdelavi.
The main measure of effectiveness was progression-free survival (how long the patients lived without the disease getting worse).
Glavno merilo učinkovitosti je bilo preživetje brez napredovanja bolezni (čas, ki so ga bolniki preživeli brez poslabšanja bolezni).
This means that it blocks certain enzymes known as tyrosine kinases.
To pomeni, da zavira specifične encime, imenovane tirozin-kinaze.
Therefore, the Committee concluded that there were insufficient data to establish the benefits of Masican.
Zato je Odbor sklenil, da ni bilo zadostnih podatkov za določitev koristi zdravila Masican.
By blocking these receptors, Masican might help in controlling cell division and thereby slow down the growth of the cancer.
Z zaviranjem teh receptorjev lahko zdravilo Masican pomaga pri nadzorovanju celične delitve ter s tem upočasni rast raka.
At the time of the initial evaluation, the CHMP was concerned that the study was not designed to compare Masican with sunitinib and that it was difficult to interpret the results.
V času prvotne ocene je imel CHMP pomislek, da študija ni bila zasnovana za primerjavo zdravila Masican s sunitinibom in da je bilo težko interpretirati rezultate.
The company that applied for authorisation is AB Science.
Vlogo za dovoljenje je predložila družba AB Science.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014.
Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 20. marca 2014 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further.
faze‟, raziskovalna študija, s katero so želeli preveriti, ali bi bilo zdravilo vredno nadalje raziskati.
During the re-examination, although the medicine's safety was of less concern, the Committee still had major concerns about the medicine's benefits.
Med ponovnim pregledom, pri katerem varnost zdravila ni bila v ospredju, je imel Odbor še vedno velike pomisleke glede koristi zdravila.
Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014
Zavrnitev vloge za dovoljenje za promet z zdravilom Masican (masitinib) EMA/167920/2014
Finally, there were concerns about the quality control of the medicine during manufacture, which led to uncertainties about the impurities that patients would be exposed to.
Poleg tega so se pojavili pomisleki o nadzoru kakovosti zdravila med proizvodnjo, kar je vodilo do negotovosti glede nečistot, ki bi jim bili izpostavljeni bolniki.
The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class.
Študija je vključevala skupino bolnikov, ki so prejemali zdravljenje z zdravilom Masican, in eno skupino, ki je prejemala zdravljenje s sunitinibom, drugim zdravilom iz istega razreda.
What is Masican?
Kaj je zdravilo Masican?
The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects.
CHMP je prav tako izrazil pomislek, da so bili podatki o varnosti na voljo samo za nekaj bolnikov, ki so prejemali zdravljenje z zdravilom Masican v predlaganem odmerku, in da to ni omogočilo ustrezne ocene neželenih učinkov zdravila.
On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST).
Odbor za zdravila za uporabo v humani medicini (CHMP) je 21. novembra 2013 sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Masican, namenjenim za zdravljenje malignega gastrointestinalnega stromalnega tumorja (gastrointestinal stromal tumourGIST).
Refusal of the marketing authorisation for Masican (masitinib)
Zavrnitev vloge za dovoljenje za promet z zdravilom Masican (masitinib)
Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer.
Zdravilo Masican naj bi se uporabljalo za zdravljenje gastrointestinalnega stromalnega tumorja, raka želodca in črevesja pri odraslih, pri katerih raka ni mogoče kirurško odstraniti ali pa se je razširil in se stanje slabša kljub zdravljenju z imatinibom, drugim zdravilom za zdravljenje te vrste raka.
Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
Čeprav se je zdelo, da so bolniki iz skupine, ki je prejemala zdravljenje z zdravilom Masican, živeli dlje od bolnikov, ki so prejemali zdravljenje s sunitinibom, možnosti, da je bila to zgolj naključna ugotovitev, ni bilo mogoče izključiti zaradi raziskovalne narave študije in zaradi pomanjkanja drugih podpornih dokazov.
Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Odbor CHMP je zato zaključil, da koristi zdravila Masican niso večje od z njim povezanih tveganj, in ostal pri svojem prejšnjem priporočilu, da naj se dovoljenje za promet zanj zavrne.
The applicant presented results of a main study in 44 patients with GIST that could not be removed surgically or that had spread and was resistant to imatinib treatment.
Predlagatelj je predstavil rezultate glavne študije pri 44 bolnikih z gastrointestinalnim stromalnim tumorjem, ki ga ni bilo mogoče kirurško odstraniti ali se je razširil in je bil odporen na zdravljenje z imatinibom.
The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor.
Zdravilna učinkovina zdravila Masican, masitinib, je zaviralec tirozin-kinaze.
Masican is an anticancer medicine that contains the active substance masitinib.
Masican je zdravilo proti raku, ki vsebuje zdravilno učinkovino masitinib.
What was Masican expected to be used for?
Za kaj naj bi se zdravilo Masican uporabljalo?
Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST.
Zdravilo Masican je bilo dne 21. decembra 2004 določeno kot „zdravilo sirota‟ (zdravilo za zdravljenje redkih bolezni) za zdravljenje malignega gastrointestinalnega stromalnega tumorja.
How is Masican expected to work?
Kako naj bi zdravilo Masican delovalo?
surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti encimi so na nekaterih receptorjih na površini rakavih celic, med drugim tudi na receptorjih, ki pospešujejo nenadzorovano deljenje celic.
It is given to newborn calves once a day for one week.
Daje se novorojenim teletom enkrat na dan v obdobju enega tedna.
The infection is known as cryptosporidiosis.
Okužba je znana kot kriptosporidioza.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom tega parazita, ki se širijo z iztrebki telet.
The full EPAR for Halagon 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 Halagon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Halagon primerljivo raven kakovosti kot zdravilo Halocur.
The company provided data on the quality and manufacture of Halagon.
Družba je priskrbela podatke o kakovosti in proizvodnji zdravila Halagon.
For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea.
Za preprečevanje driske je treba zdravljenje uvesti 24 do 48 ur po skotitvi, za zmanjševanje driske pa v 24 urah po pojavu driske.
This is a summary of the European public assessment report (EPAR) for Halagon.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Halagon.
What are the benefits and risks of Halagon?
Kakšne so koristi in tveganja, povezani z zdravilom Halagon?
Halagon is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Halagon je zdravilo, ki se uporablja za zdravljenje novorojenih telet za preprečevanje in zmanjševanje driske, ki jo povzroča organizem, imenovan Cryptosporidium parvum.
The withdrawal period for meat from newborn calves treated with Halagon is 13 days.
Karenca za meso novorojenih telet, zdravljenih z zdravilom Halagon, je 13 dni.
Halagon is a ‘generic medicine'.
Zdravilo Halagon je „generično zdravilo“.
It is not intended to provide practical advice on how to use Halagon.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The active substance in Halagon, halofuginone, prevents the growth of Cryptosporidium parvum.
Zdravilna učinkovina v zdravilu Halagon, halofuginon, preprečuje rast parazita Cryptosporidium parvum.
Halagon should be given after feeding.
Zdravilo Halagon je treba dajati po hranjenju.
This means that Halagon is similar to a ‘reference medicine' already authorised in the EU called Halocur.
To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Halocur.
Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Izdaja zdravila Halagon je le na recept in je na voljo v obliki peroralne raztopine (tekočine, ki se daje skozi usta).
The Committee recommended that Halagon be approved for use in the EU.
Priporočil je, da se zdravilo Halagon odobri za uporabo v EU.
What is Halagon and what is it used for?
Kaj je zdravilo Halagon in za kaj se uporablja?
Halagon EMA/664633/2016
EMA/848943/2016 Halagon stran 2/2
The medicine contains the active substance halofuginone.
Zdravilo vsebuje zdravilno učinkovino halofuginon.
Why is Halagon approved?
Zakaj je bilo zdravilo Halagon odobreno?
Because Halagon is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Halagon generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a parasite belonging to the ‘protozoa' family that invades the digestive system, causing diarrhoea.
To je parazit, ki spada v družino protozojev in vdre v prebavni sistem ter povzroča drisko.
Other information about Halagon?
Druge informacije o zdravilu Halagon
It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite that are passed in the faeces.
Prav tako omejuje širjenje bolezni, tako da preprečuje nastajanje oocist, tj. stopnje v življenjskem ciklu
For more information about treatment with Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Halagon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Safety information has been included in the summary of product characteristics and the package leaflet for Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine.
Ker je zdravilo Halagon generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
For practical information about using Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Halagon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Therefore, the CVMP's view was that, as for Halocur, the benefits outweigh the identified risks.
Zato je menil, da njegove koristi enako kot pri zdravilu Halocur odtehtajo znana tveganja.
How does Halagon work?
Kako zdravilo Halagon deluje?
No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations.
Ker je zdravilo Halagon peroralna raztopina na osnovi vode, ki vsebuje enako zdravilno učinkovino in sestavine v enakih koncentracijah kot referenčno zdravilo, niso bile potrebne nobene dodatne študije.
How is Halagon used?
Kako se zdravilo Halagon uporablja?
The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016.
Evropska komisija je dovoljenje za promet z zdravilom Halagon, veljavno po vsej Evropski uniji, izdala
How has Halagon been studied?
Kako je bilo zdravilo Halagon raziskano?
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
The Healthcare Professional Guide should contain the following key messages:
Priročnik za zdravstveno osebje mora vsebovati naslednja ključna sporočila:
The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Države članice se dogovorijo o končnem izobraževalnem gradivu z imetnikom dovoljenja za promet pred začetkom trženja zdravila na njihovem območju.
• That Vibativ has a risk of nephrotoxicity including increased risk of mortality in patients with pre existing acute renal failure and is therefore contraindicated in patients with pre-existing acute renal failure and in patients with creatinine clearance < 30ml/min, including patients undergoing haemodialysis.
• Da se pri zdravilu Vibativ pojavlja tveganje za nefrotoksičnost, vključno s povečanim tveganjem smrtnosti pri bolnikih s predhodno akutno ledvično odpovedjo in je zato kontraindicirano pri bolnikih s predhodno akutno ledvično odpovedjo ter pri bolnikih z očistkom kreatinina < 30ml/min, vključno z bolniki na hemodializi.
• Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
• Zdravstveno osebje se mora zavedati, da lahko uporaba zdravila Vibativ ovira nekatere teste koagulacije in kakovostne in količinske analize beljakovin v urinu.
• The need to counsel patients on important risks associated with Vibativ therapy and appropriate precautions when using the medicine.
• Potreba po svetovanju bolnikom o pomembnih tveganjih, ki so povezana z zdravljenjem z zdravilom Vibativ ter ustrezni varnostni ukrepi ob uporabi zdravila.
• That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy.
• Da obstaja potencialno tveganje za teratogenost in da je zdravilo Vibativ v času nosečnosti kontraindicirano.