FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Potactasol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Potactasol je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What are the benefits and risks of Potactasol?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Potactasol?
English: The company has provided data from the published literature on topotecan.
Slovenian: Družba je predstavila podatke o topotekanu iz objavljene literature.
English: This is a summary of the European public assessment report (EPAR) for Potactasol.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Potactasol.
English: This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Hycamtin.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Potactasol.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For more information about treatment with Potactasol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Potactasol preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Slovenian: Zdravljenje z zdravilom Potactasol lahko poteka samo pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
English: It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix).
Slovenian: Zdravilo se uporablja tudi skupaj s cisplatinom (drugo vrsto zdravila proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v napredovalem stadiju (rak se je razširil zunaj materničnega vratu).
English: Other information about Potactasol
Slovenian: Druge informacije o zdravilu Potactasol
English: Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Potactasol generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The Committee recommended that Potactasol be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Potactasol izda dovoljenje za promet.
English: Potactasol also affects non-cancer cells, which causes side effects.
Slovenian: Zdravilo Potactasol vpliva tudi na nerakave celice, kar povzroča neželene učinke.
English: The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Potactasol primerljivo z zdravilom Hycamtin.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Slovenian: Odmerek zdravila Potactasol je odvisen od vrste raka, ki se zdravi, ter bolnikove telesne mase in višine.
English: When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Slovenian: Če se zdravilo Potactasol uporablja skupaj s cisplatinom za zdravljenje raka materničnega vratu, se daje v obliki infuzije 1., 2. in 3. dan (cisplatin se daje 1. dan).
English: For both ovarian and lung cancer, Potactasol is given every day for five days with a three-week interval between the start of each course.
Slovenian: Pri raku jajčnikov in pljučnem raku se zdravilo Potactasol daje vsak dan pet dni, čemur sledi tritedenski premor pred pričetkom novega cikla zdravljenja.
English: The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Slovenian: Zdravilna učinkovina zdravila Potactasol, topotekan, je zdravilo za zdravljenje raka, ki spada v skupino zaviralcev topoizomeraze.
English: Why has Potactasol been approved?
Slovenian: Zakaj je bilo zdravilo Potactasol odobreno?
English: When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes.
Slovenian: Če se rak jajčnikov zdravi zgolj z zdravilom Potactasol, se ta daje z več kot 30-minutno infuzijo.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Hycamtin, odtehtajo znana tveganja.
English: Potactasol is a ‘generic medicine'.
Slovenian: Zdravilo Potactasol je „generično zdravilo“.
English: Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects.
Slovenian: Glede na neželene učinke bo morda treba odmerke zdravila Potactasol prilagoditi ali zdravljenje odložiti.
English: Potactasol is a medicine that contains the active substance topotecan.
Slovenian: Potactasol je zdravilo, ki vsebuje zdravilno učinkovino topotekan.
English: No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Slovenian: Ker je zdravilo Potactasol generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, niso bile potrebne nobene dodatne študije.
English: How has Potactasol been studied?
Slovenian: Kako je bilo zdravilo Potactasol raziskano?
English: What is Potactasol used for?
Slovenian: Za kaj se zdravilo Potactasol uporablja?
English: What is Potactasol?
Slovenian: Kaj je zdravilo Potactasol?
English: Potactasol is a cancer medicine.
Slovenian: Potactasol je zdravilo proti raku.
English: How is Potactasol used?
Slovenian: Kako se zdravilo Potactasol uporablja?
English: How does Potactasol work?
Slovenian: Kako zdravilo Potactasol deluje?
English: Route of Administration
Slovenian: Velikost pakiranja
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented:
Slovenian: Države članice morajo zagotoviti uvedbo vseh pogojev ali omejitev v zvezi z varno in učinkovito uporabo medicinskih izdelkov, kot je opisano spodaj:
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Slovenian: • Povzetek lastnosti zdravila (SPC) z navodilom za uporabo in označbo
English: • The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Slovenian: o Da je tveganje infuzijskih reakcij reakcij najvišje v prvem tednu zdravljenja o Če je reakcija zmerna ali močna, se mora odmerna shema nadaljevati pri z enako stopnjo (to pomeni brez zvečanja odmerka), dokler bolnik odmerka ne prenese dobro o Če je bilo zdravljenje prekinjeno za več kot 7 dni, je treba MabCampath ponovno uvesti s postopnim stopnjevanjem odmerka
English: The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the
Slovenian: Države članice bodo zagotovile, da bo imetnik dovoljenja za promet vsem zdravnikom, ki predpisujejo zdravilo MabCampath, priskrbel strokovno zdravstveno opisno dokumentacijo, ki bo vsebovala naslednje:
English: - To agree the details of an educational brochure with the MAH.
Slovenian: Dogovoriti se z imetnikom dovoljenja za promet o podrobnostih za izobraževalno brošuro.
English: This summary was last updated on 30/08/2012.
Slovenian: Povzetek je bil nazadnje posodobljen dne 30/08/2012.
English: It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).
Slovenian: Zdravilo je raztopina za injiciranje (0,1 mg/ml in 0,5 mg/ml).
English: In addition, the blood pressure will increase before returning to normal or below normal.
Slovenian: Poleg tega se krvni tlak najprej poviša in se nato vrne na normalno raven ali pod njo.
English: The marketing authorisation was renewed on 2 August 2007.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 2. avgusta 2007.
English: Dexdomitor dexmedetomidine
Slovenian: Dexdomitor deksmedetomidin
English: The duration and depth of sedation and analgesia depend on the dose that is used.
Slovenian: Trajanje in globina sedacije in analgezije sta odvisna od uporabljenega odmerka.
English: It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Slovenian: Deluje tako, da preprečuje sproščanje živčnega prenašalca noradrenalina iz živčnih celic telesa.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dexdomitor on 30 August 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dexdomitor, veljavno po vsej Evropski uniji, odobrila dne 30. avgusta 2002.
English: • Before inducing general anaesthesia.
Slovenian: • pred uvedbo splošne anestezije.
English: Dexmedetomidine is an alpha2-adrenoceptor agonist.
Slovenian: Deksmedetomidin, je agonist alfa2-adrenoreceptorja.
English: Pregnant women should take special care to avoid self-injection.
Slovenian: Nosečnice morajo biti še posebej previdne, da ne pride do samoinjiciranja zdravila.
English: The use of waterproof gloves is advisable.
Slovenian: Priporočljiva je uporaba nepropustnih rokavic.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Slovenian: Ker je noradrenalin udeležen pri vzdrževanju budnega stanja, zmanjšanje stopnje njegovega sproščanja zniža raven zavesti in občutek bolečine.
English: Other information about Dexdomitor:
Slovenian: Druge informacije o zdravilu Dexdomitor:
English: If contact does occur, rinsing with large amounts of water is advised.
Slovenian: Če do stika pride, je treba mesto izprati z veliko količino vode.
English: However, the person should not drive due to the risk of sedation and changes in blood pressure.
Slovenian: Vendar pa zaradi tveganja sedacije in sprememb krvnega tlaka oseba ne sme voziti.
English: The safety of the use of Dexdomitor has not been studied in puppies below 16 weeks of age or in kittens below 12 weeks of age.
Slovenian: Varnost uporabe zdravila Dexdomitor ni bila preverjena pri kužkih, mlajših od 16 tednov, ali muckah, mlajših od 12 tednov.
English: As for medetomidine, ‘good' or ‘excellent' analgesia was reached in about 40 to 50 % of the animals, supporting its used in non-invasive mildly to moderately painful procedures.
Slovenian: Kar zadeva medetomidin, so pri 40 do 50 % živali dosegli „dobro“ ali „odlično“ analgezijo, kar je v prid uporabi tega zdravila pri neinvazivnih, blago do zmerno bolečih posegih.
English: It is used in non-invasive procedures which do not involve breaking the skin or a body cavity.
Slovenian: Uporablja se pri neinvazivnih posegih, kar pomeni, da se pri postopku ne predre kože ali stene telesne votline;
English: The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia.
Slovenian: Študije so vključevale pse in mačke različnih starosti in pasem, na katerih so morali izvesti postopke, ki so zahtevali sedacijo ali analgezijo.
English: What benefit has Dexdomitor shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dexdomitor izkazalo med študijami?
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Slovenian: Deksmedetomidin je tesno povezan z drugo snovjo, ki se uporablja za sedacijo živali, medetomidinom, ki ga v veterinarskih zdravilih uporabljajo že dolga leta.
English: Vomiting may occur five to 10 minutes after injection or at the time of recovery.
Slovenian: Pet do deset minut po vbrizganju ali v času prenehanja delovanja zdravila lahko pride do bruhanja.
English: 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.
Slovenian: Pri nekaterih psih in mačkah se lahko zmanjša hitrost dihanja, sluznična membrana pa je lahko videti bleda ali modrikasta.
English: • For deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
Slovenian: • za globoko sedacijo in analgezijo pri psih ob sočasni uporabi z butorfanolom (sedativom in analgetikom) za postopke, ki vključujejo manjše kirurške posege.
English: • 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).
Slovenian: • kadar se izvajajo blago do zmerno boleči postopki in pregledi, pri katerih mora biti žival ukročena ali mirna ter manj občutljiva na bolečino (analgezija).
English: Dexdomitor causes a decrease in heart rate and body temperature.
Slovenian: Zdravilo Dexdomitor povzroči upočasnitev bitja srca in zmanjšanje telesne temperature.
English: The CVMP concluded that the benefits of Dexdomitor exceed the risks and recommended that it be given a marketing authorisation.
Slovenian: 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.
English: When used in cats, ketamine should be used as the anaesthetic agent.
Slovenian: Kadar se uporablja pri mačkah, je treba kot anestetično sredstvo uporabiti ketamin;
English: Information on the prescription status of this product may be found on the label/outer package.
Slovenian: Podatki o predpisovanju zdravila so navedeni na nalepki/zunanji ovojnini.
English: Other side effects can occur when Dexdomitor is used with other medicines.
Slovenian: Drugi neželeni učinki se lahko pojavijo, če se zdravilo Dexdomitor uporablja sočasno z drugimi zdravili.
English: Dexdomitor is used to sedate (calm down) dogs and cats in the following situations:
Slovenian: Zdravilo Dexdomitor se uporablja za sedacijo (pomiritev) psov in mačk v naslednjih primerih:
English: 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.
Slovenian: 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.
English: What is the risk associated with Dexdomitor?
Slovenian: Kakšna tveganja so povezana z zdravilom Dexdomitor?
English: People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.
Slovenian: Osebe z znano preobčutljivostjo na deksmedetomidin ali katero koli drugo sestavino zdravila morajo zdravilo dajati previdno.
English: The dose depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats.
Slovenian: Odmerek je pri psih odvisen od telesne površine (izračuna se s pomočjo telesne mase), pri mačkah pa od telesne mase.
English: Why has Dexdomitor been approved?
Slovenian: Zakaj je bilo zdravilo Dexdomitor odobreno?
English: Dexdomitor was investigated in studies involving dogs and cats in which its effectiveness was compared with that of medetomidine.
Slovenian: Zdravilo Dexdomitor so proučevali v študijah pri psih in mačkah, v katerih so njegovo učinkovitost primerjali z učinkovitostjo medetomidina.
English: 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.
Slovenian: Če se zdravilo Dexdomitor nenamerno injicira ali nenamerno zaužije, je treba nemudoma poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
English: Contact with the skin, eyes of mucous (moist body surfaces) should be avoided.
Slovenian: Izogibati se je treba tudi stiku zdravila s kožo, očmi ali sluznico (vlažnimi površinami telesa).
English: 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.
Slovenian: 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.
English: In cats, it is given by intramuscular injection.
Slovenian: Mačkam se zdravilo daje z intramuskularno injekcijo.
English: Dexdomitor contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
Slovenian: Zdravilo Dexdomitor vsebuje zdravilno učinkovino deksmedetomidin, ki spada v razred zdravil s psiholeptičnimi (pomirjevalnimi) učinki.
English: The studies showed that Dexdomitor had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats.
Slovenian: Študije so pokazale, da je imelo zdravilo Dexdomitor enakovreden učinek kot medetomidin pri sedaciji in analgeziji psov in mačk.
English: Finally, it was studied as a premedication in dogs and cats prior to induction of general anaesthesia.
Slovenian: Nenazadnje so zdravilo proučevali tudi kot pripravo na poseg pri psih in mačkah pred uvajanjem splošne anestezije.
English: In dogs, Dexdomitor is given by intravenous or intramuscular injection.
Slovenian: Psom se zdravilo Dexdomitor daje z intravensko ali intramuskularno injekcijo.
English: In dogs, both intravenous and intramuscular injections of Dexdomitor were studied.
Slovenian: Pri psih so proučevali tako intravenske kot intramuskularne injekcije zdravila Dexdomitor.
English: What is Dexdomitor used for?
Slovenian: Za kaj se zdravilo Dexdomitor uporablja?
English: 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.
Slovenian: 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.
English: How does Dexdomitor work?
Slovenian: Kako zdravilo Dexdomitor deluje?
English: For a full list of all side effects reported with Dexdomitor, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dexdomitor, glejte navodilo za uporabo.
English: How has Dexdomitor been studied?
Slovenian: Kako je bilo zdravilo Dexdomitor raziskano?
English: 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.
Slovenian: 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.
English: Dexdomitor was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine.
Slovenian: Zdravilo Dexdomitor je bilo pri vzpostavljanju stanja splošne anestezije pri mačkah ob sočasni uporabi ketamina vsaj tako učinkovito kot medetomidin.
English: 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.
Slovenian: Med sedacijo se lahko pojavi drgetanje mišic, roženica pa lahko postane motna (motna mesta v prozornem delu očesa pred zenico).
English: What is Dexdomitor?
Slovenian: Kaj je zdravilo Dexdomitor?
English: 60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups
Slovenian: 60 vrečic + dve 1-ml brizgi + dve 3-ml brizgi + dve 10-ml brizgi + 2 posodici za mešanje
English: Granules for oral suspension sachet (PET/Alu/LLDPE)
Slovenian: 100 mg zrnca za peroralno suspenzijo peroralna uporaba vrečica (PET/Alu/LLDPE)
English: 21 March 2014 EMA/167920/2014 EMEA/H/C/002670
Slovenian: 21. marec 2014 EMA/167920/2014 EMEA/H/C/002670
English: In addition, there were still outstanding problems related to quality control during its manufacture.
Slovenian: Poleg tega je bilo še vedno nekaj nerešenih težav, povezanih z nadzorom kakovosti pri njegovi izdelavi.
English: The main measure of effectiveness was progression-free survival (how long the patients lived without the disease getting worse).
Slovenian: Glavno merilo učinkovitosti je bilo preživetje brez napredovanja bolezni (čas, ki so ga bolniki preživeli brez poslabšanja bolezni).
English: This means that it blocks certain enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira specifične encime, imenovane tirozin-kinaze.
English: Therefore, the Committee concluded that there were insufficient data to establish the benefits of Masican.
Slovenian: Zato je Odbor sklenil, da ni bilo zadostnih podatkov za določitev koristi zdravila Masican.
English: By blocking these receptors, Masican might help in controlling cell division and thereby slow down the growth of the cancer.
Slovenian: Z zaviranjem teh receptorjev lahko zdravilo Masican pomaga pri nadzorovanju celične delitve ter s tem upočasni rast raka.
English: 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.
Slovenian: 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.
English: The company that applied for authorisation is AB Science.
Slovenian: Vlogo za dovoljenje je predložila družba AB Science.
English: 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.
Slovenian: 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.