natgillin/translations-raw huggingface dataset:
As for all medicines, data on the use of PecFent are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila PecFent stalno spremljajo.
What are the risks associated with PecFent?
Kakšna tveganja so povezana z zdravilom PecFent?
PecFent is a ‘hybrid medicine'.
Zdravilo PecFent je „hibridno zdravilo“.
In this study, patients reported that they were ‘satisfied' or ‘very satisfied' with PecFent treatment for around 90% of breakthrough pain episodes.
V tej študiji so bolniki poročali, da so z zdravljenjem z zdravilom PecFent „zadovoljni“ ali „zelo zadovoljni“ pri približno 90 % epizod prebijajoče bolečine.
What benefits of PecFent have been shown in studies?
Kakšne koristi zdravila PecFent so se pokazale v študijah?
When a patient starts to take PecFent the doctor will need to work out the appropriate dose that will provide adequate pain relief with as few side effects as possible.
Ko začne bolnik prejemati zdravilo PecFent, mora zdravnik določiti ustrezen odmerek, ki bo zagotovil primerno lajšanje bolečin s čim manj neželenimi učinki.
Why is PecFent authorised in the EU?
Zakaj je bilo zdravilo PecFent odobreno v EU?
The doctor should keep in mind the potential for PecFent to be abused.
Zdravnik se mora zavedati, da obstaja možnost zlorabe zdravila PecFent.
Side effects reported with PecFent are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu PecFent, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The European Medicines Agency noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer.
Evropska agencija za zdravila ugotovila, da obstaja potreba po hitro delujočih protibolečinskih zdravilih za zdravljenje prebijajoče bolečine pri bolnikih z rakom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of PecFent have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila PecFent upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The company that markets PecFent will provide educational materials in each EU Member State to make sure that patients, doctors and pharmacists are aware of how PecFent should be used, the risk of accidental exposure to fentanyl and how to dispose of the medicine.
Podjetje, ki trži zdravilo PecFent, bo v vseh državah članicah EU priskrbelo izobraževalno gradivo in z njim zagotovilo, da so bolniki, zdravniki in farmacevti seznanjeni s pravilno uporabo zdravila PecFent, tveganjem v primeru nenamerne izpostavitve fentanilu in načinom odstranjevanja zdravila.
PecFent is available as a nasal spray (100 and 400 micrograms per spray) and can only be obtained by ‘special' prescription.
Zdravilo PecFent je na voljo kot pršilo za nos (100 in 400 mikrogramov na vpih pršila), njegovo predpisovanje in izdaja pa je le na „poseben“ recept.
For more information about using PecFent, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila PecFent glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is PecFent and what is it used for?
Kaj je zdravilo PecFent in za kaj se uporablja?
PecFent must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Zdravila PecFent ne smejo uporabljati bolniki, ki še ne jemljejo opioidov za vzdrževanje nadzora nad bolečino, in bolniki, ki imajo resno depresijo dihanja (oteženo dihanje) ali obolenje s hudo obstrukcijo pljuč (bolezen, pri kateri je dihanje močno ovirano).
In one main study, PecFent was shown to be more effective than placebo (a dummy treatment) at treating breakthrough cancer pain in 83 adults who were being treated with opioids.
V eni glavni študiji se je pokazalo, da je zdravilo PecFent za zdravljenje prebijajoče bolečine učinkovitejše kot placebo (zdravilo brez učinkovine) pri 83 odraslih z rakom, ki so se zdravili z opioidi.
When the patient sprays PecFent into the nose, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels in the nose.
Ko si bolnik naprši zdravilo PecFent v nos, se odmerek fentanila skozi krvne žile v nosu hitro absorbira v krvni obtok.
The doses should be given as either one spray or two sprays of the same strength.
Zdravilo je treba odmerjati bodisi z enim ali dvema vpihoma pršila enake jakosti.
An additional study measured the ‘acceptability' of PecFent by the patients, rating how satisfied they were with PecFent, and how easy and convenient they found it to use.
V dodatni študiji so merili „sprejemljivost“ zdravila PecFent, in sicer so bolniki ocenjevali zadovoljstvo z zdravilom PecFent ter enostavnost in priročnost njegove uporabe.
While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.
Medtem ko se referenčni zdravili Effentora (bukalne tablete) in Actiq (pastile) dajeta peroralno, se zdravilo PecFent daje kot pršilo v nos.
Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
O prebijajoči bolečini govorimo takrat, ko bolnik občuti nenadno dodatno bolečino, čeprav že prejema protibolečinska zdravila.
It must not be used to treat short-term pain other than breakthrough pain.
Zdravilo se ne sme uporabljati za zdravljenje drugih vrst kratkotrajnih bolečin.
PecFent is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Zdravilo PecFent se uporablja pri bolnikih, ki že jemljejo opioide (zdravila iz skupine protibolečinskih zdravil, kamor spadata morfin in fentanil) za obvladovanje dolgotrajne bolečine pri raku.
PecFent is a medicine used to treat breakthrough pain in adult patients with cancer.
PecFent je zdravilo za zdravljenje prebijajoče bolečine pri odraslih bolnikih z rakom.
The active substance in PecFent, fentanyl, is an opioid.
Učinkovina v zdravilu PecFent, fentanil, je opioid.
Treatment with PecFent should be started by and remain under the supervision of a doctor who has experience in managing opioid treatment in cancer patients.
Zdravljenje z zdravilom PecFent sme uvesti in ves čas voditi le zdravnik, ki ima izkušnje z izvajanjem zdravljenja z opioidi pri bolnikih z rakom.
How is PecFent used?
Kako se zdravilo PecFent uporablja?
PecFent contains the active substance fentanyl.
Zdravilo PecFent vsebuje učinkovino fentanil.
Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine.
Ti s stalno uporabo zdravila pogosto izginejo ali postanejo manj intenzivni.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Fentanil začne z vstopom v krvni obtok delovati na receptorje v možganih in hrbtenjači ter tako nadzoruje bolečino.
For the full list of side effects reported with PecFent, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PecFent, glejte navodilo za uporabo.
How does PecFent work?
Kako zdravilo PecFent deluje?
There were also deficiencies identified in the manufacturing process of the medicine.
Pomanjkljivosti so bile ugotovljene tudi v postopku izdelave zdravila.
In addition, the safety profile and the way the medicine is expected to work in the body had not been sufficiently characterised.
Poleg tega varnostni profil in pričakovani način delovanja zdravila v telesu nista bila zadovoljivo opredeljena.
Withdrawal of the marketing authorisation application for Begedina (begelomab) EMA/579473/2016
Umik vloge za pridobitev dovoljenja za promet z zdravilom Begedina (begelomab) EMA/579462/2016
In its letter notifying the Agency of the withdrawal of application, the company stated that it acknowledges the need to obtain additional data from a confirmatory study.
Družba je v dopisu, s katerim je Agencijo obvestila o umiku vloge, navedla, da se strinja, da je treba pridobiti dodatne podatke iz potrditvene študije.
What is Begedina?
Kaj je zdravilo Begedina?
Begedina is a medicine that contains the active substance begelomab.
Begedina je zdravilo, ki vsebuje zdravilno učinkovino begelomab.
In the studies, Begedina was not compared with any other treatment.
V teh študijah zdravila Begedina niso primerjali z nobenim drugim zdravilom.
The medicine was for use in patients whose disease did not respond to treatment with steroids.
Zdravilo naj bi se uporabljalo pri bolnikih, pri katerih se bolezen ni odzvala na zdravljenje s steroidi.
Begedina was expected to be used for the treatment of acute graft-versus-host disease (a condition in which transplanted cells attack the patient's body) in adults who have had haematopoietic progenitor cell transplantation (transplant of cells that can develop into different types of blood cells) from a donor.
Zdravilo Begedina naj bi se uporabljalo za zdravljenje akutne bolezni presadka proti gostitelju (stanja, pri katerem presajene celice napadejo bolnikovo telo) pri odraslih, ki so jim presadili darovalčeve krvotvorne matične celice (presajene celic, ki se lahko razvijejo v različne vrste krvnih celic).
activity of T cells from the transplant that attack the patient's organs, thereby helping to control graftversus-host disease.
aktivnost celic T s presadka, ki napadajo bolnikove organe, in tako nadzorovalo bolezen presadka proti gostitelju.
The company presented the results of two studies with Begedina involving a total of 29 adults with acute graft-versus-host disease that did not respond to steroid treatment.
Družba je predstavila rezultate dveh študij z zdravilom Begedina, ki sta skupaj vključevali 29 odraslih z akutno boleznijo presadka proti gostitelju, ki se ni odzvala na zdravljenje s steroidi.
On 4 July 2016, Adienne S.r.l.
Družba Adienne S.r.l.
Begedina was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 November 2010 for treatment of graft-versus-host disease.
Zdravilo Begedina je bilo dne 26. novembra 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje bolezni presadka proti gostitelju.
Withdrawal of the marketing authorisation application for Begedina (begelomab)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Begedina (begelomab)
It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The CHMP considered that the data provided were insufficient to demonstrate a beneficial effect of Begedina.
CHMP je menil, da predloženi podatki ne zadoščajo za dokaz koristnega učinka zdravila Begedina.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Begedina.
Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Begedina.
By attaching to CD26, this medicine is expected to reduce the rate at which the T cells multiply.
S pritrditvijo na CD26 naj bi to zdravilo zmanjšalo hitrost razmnoževanje celic T. S tem naj bi se zmanjšalo število in
Based on the review of the available data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Begedina could not have been approved for the treatment of acute graft-versus-host disease that did not respond to steroid treatment.
Na podlagi pregleda razpoložljivih podatkov je odbor CHMP v času umika izrazil določene zadržke in je začasno menil, da zdravila Begedina ni mogoče odobriti za zdravljenje bolnikov z akutno boleznijo presadka proti gostitelju, ki se ni odzvala na zdravljenje s steroidi.
What was Begedina expected to be used for?
Za kaj naj bi se zdravilo Begedina uporabljalo?
The active substance in Begedina, begelomab, is a monoclonal antibody (a type of protein) that has been designed to attach itself to a receptor called CD26, which is present on T cells.
Zdravilna učinkovina v zdravilu Begedina, begelomab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se pritrdi na receptor, imenovan CD26, ki je prisoten na površini celic T. Te so vrsta belih krvnih celic, ki so vključene v bolezen presadka proti gostitelju.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Begedina.
Zato je CHMP v času umika menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Begedina.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease.
je dne 4. julija 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Begedina, namenjenim zdravljenju bolezni presadka proti gostitelju.
How was Begedina expected to work?
Kako naj bi zdravilo Begedina delovalo?
The referral procedure started on 12 October 2011.
Napotitveni postopek se je začel 12. oktobra 2011.
The final opinion was converted into a Decision by the European Commission on 17 December 2012.
Končno mnenje je bilo spremenjeno v Sklep Evropske komisije dne 17. decembra 2012.
1 Article 35 of Directive 2001/82/EC, as amended
1 Člen 35 Direktive 2001/82/ES, kakor je bila spremenjena.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Seznam zadevnih imen zdravila je predložen v Prilogi I. Znanstveni zaključki so navedeni v Prilogi II.
The Committee appointed Dr M. Holzhauser-Alberti as rapporteur and Dr C. Muñoz Madero as co-rapporteur.
Odbor je imenoval dr. M. Holzhauser-Albertija za poročevalca in dr. C. Muñoz Madera za soporočevalca.
International non-proprietary name (inn): enrofloxacin Background information
Mednarodno nelastniško ime (INN): enrofloksacin Osnovne informacije
Supplementary information was provided in writing by an applicant and marketing authorisation holders on 16 January 2012.
Predlagatelj in imetniki dovoljenja za promet z zdravilom so 16. januarja 2012 predložili dodatne informacije v pisni obliki.
The dosage is 10 mg enrofloxacin per kg bodyweight during 5 days.
Velikost odmerka je 10 mg enrofloksacina na kg telesne mase 5 dni.
The pharmaceutical form is an oral solution administered via the drinking water.
Farmacevtska oblika zdravila je peroralna raztopina, ki se daje s pitno vodo.
On 14 May 2012, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to antimicrobial resistance and the prudent use of antimicrobials in veterinary medicine.
Evropska komisija je 14. maja 2012 zahtevala, da CVMP ponovno preuči svoje mnenje ter pojasni nekatere vidike odpornosti proti mikrobom in preudarne uporabe protimikrobnih sredstev v veterinarski medicini.
HIPRALONA ENRO-S and its generics are veterinary medicinal products which contain enrofloxacin as active substance, and are indicated in rabbits for the treatment of respiratory infections caused by Pasteurella multocida.
Zdravilo HIPRALONA ENRO-S in njegova generična zdravila so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino enrofloksacin in so indicirana za zdravljenje okužb dihal pri kuncih, ki jih povzroča Pasteurella multocida.
Based on the evaluation of the available data, on 11 April 2012, the CVMP adopted by majority an opinion recommending the maintenance of the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics in accordance with the previously approved product information.
Na osnovi ocene razpoložljivih podatkov je CVMP 11. aprila 2012 z večino sprejel mnenje, v katerem priporoča ohranitev dovoljenj za promet z zdravilom za uporabo v veterinarski medicini HIPRALONA ENRO-S in njegovimi generičnimi zdravili v skladu s predhodno odobrenimi informacijami o zdravilu.
On 13 September 2012, the CVMP adopted by majority a revised opinion confirming the recommendation, included in its opinion of 11 April 2012, that the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics should be maintained in accordance with the previously approved product information.
CVMP je 13. septembra 2012 z večino sprejel ponovno preučeno mnenje, s katerim potrjuje priporočilo, ki je bilo vključeno v njegovo mnenje z dne 11. aprila 2012, da je treba ohraniti dovoljenja za promet z zdravilom za uporabo v veterinarski medicini HIPRALONA ENRO-S in njegovimi generičnimi zdravili v skladu s predhodno odobrenimi informacijami o zdravilu.
On 30 September 2011, France initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits, due to concerns that the use of the products in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Francija je zaradi pomislekov, da bi uporaba zdravil pri proizvodnji kuncev povečala odpornost Escherichia coli in Staphylococcus aureus na enrofloksacin, 30. septembra 2011 sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo za uporabo v veterinarski medicini HIPRALONA ENRO-S in njegova generična zdravila, indicirana za uporabo pri kuncih.
The use of Enviage in children and adolescents is not recommended.
Uporaba zdravila Enviage pri otrocih in mladostnikih ni priporočena.
If you forget to take Enviage
Če ste pozabili vzeti zdravilo Enviage
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Enviage.
Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost, morate dobro poznati svoj odziv na učinke zdravila Enviage.
If you forget to take a dose of Enviage, take it as soon as you remember and then take the next dose at its usual time.
Če pozabite vzeti odmerek zdravila Enviage, ga vzemite takoj, ko se spomnite nanj in nato vzemite naslednji odmerek ob običajnem času.
Enviage has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Zdravilo Enviage so proučevali pri 1.864 bolnikih, starih 65 let ali več, in pri 426 bolnikih, starih 75 let ali več.
Your doctor may prescribe Enviage together with other medicines used to treat high blood pressure.
Zdravnik vam lahko predpiše zdravilo Enviage skupaj z drugimi zdravili za zdravljenje visokega krvnega tlaka.
Enviage has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Varnost zdravila Enviage so ocenjevali pri več kot 7.800 bolnikih, med drugim pri več kot 2.300 bolnikih, ki so bili zdravljeni več kot 6 mesecev, in pri več kot 1.200 bolnikih, ki so bili zdravljeni več kot 1 leto.
If angioedema occurs, Enviage should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Če pride do angioedema, je treba zdravljenje z zdravilom Enviage takoj prekiniti in poskrbeti za ustrezno zdravljenje in spremljanje bolnika, dokler znaki in simptomi niso v celoti in trajno odpravljeni.
If any of these apply to you, tell your doctor before you take Enviage.
Če kaj od navedenega velja za vas, povejte zdravniku, preden začnete jemati zdravilo Enviage.
In experimental animals, it has been shown that P-gp is a major determinant of Enviage bioavailability.
Na poskusnih živalih se je pokazalo, da je P-gp glavna determinanta biološke uporabnosti zdravila Enviage.
Preliminary data suggest that irbesartan may decrease Enviage AUC and Cmax.
Predhodni podatki nakazujejo, da irbesartan lahko zmanjša AUC in Cmax zdravila Enviage.
Enviage helps to lower high blood pressure.
Enviage pomaga zniževati visok krvni tlak.
Enviage was not teratogenic in rats or rabbits (see section 5.3).
Zdravilo Enviage ni bilo teratogeno pri podganah ali kuncih (glejte poglavje 5.3).
Beneficial effects of Enviage on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Ugodni vplivi zdravila Enviage na umrljivost, kardiovaskularno obolevnost in prizadetost tarčnih organov trenutno niso znani.
In diabetic hypertensive patients, Enviage monotherapy was safe and effective.
Pri sladkornih bolnikih s hipertenzijo je bila monoterapija z zdravilom Enviage varna in učinkovita.
Enviage should be taken with a light meal once a day, preferably at the same time each day.
Zdravilo Enviage je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
Do not use Enviage after the expiry date which is stated on the carton and blister.
Zdravila Enviage ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
Enviage was secreted in the milk of lactating rats.
Zdravilo Enviage se je izločalo v mleko doječih podgan.
The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 8.0 in predložen v modulu 1.8.1 vloge za pridobitev dvoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
Food intake Meals with a high fat content have been shown to reduce the absorption of Enviage substantially.
Uživanje hrane Pokazalo se je, da obroki z veliko vsebnostjo maščob bistveno zmanjšajo absorpcijo zdravila Enviage.
As for any medicine that acts directly on the RAS, Enviage should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Tako kot velja za katerokoli drugo zdravilo, ki deluje neposredno na sistem renin-angiotenzin, tudi zdravila Enviage ne smete uporabljati v prvem trimesečju nosečnosti oziroma pri ženskah, ki načrtujejo nosečnost, poleg tega je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
Like all medicines, Enviage can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Enviage neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Enviage and placebo, respectively.
Delež bolnikov, ki so imeli UACR zmanjšano za vsaj 50 % od izhodiščne vrednosti, je bil pri zdravilu Enviage 24,7 %, pri placebu pa 12,5 %.
In this leaflet: What Enviage is and what it is used for
KAJ JE ZDRAVILO ENVIAGE IN ZA KAJ GA UPORABLJAMO
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Enviage 150 mg was well tolerated.
V 3-mesečni študiji, ki je vključevala 302 bolnika z blagim, stabilnim srčnim popuščanjem, od katerih so vsi prejemali standardno terapijo pri stabilnem srčnem popuščanju, so bolniki dodajanje zdravila Enviage v odmerku 150 mg dobro prenašali.
The recommended dose of Enviage is 150 mg once daily.
Priporočeni odmerek zdravila Enviage je 150 mg enkrat dnevno.
Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Enviage pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5.2).