natgillin/translations-raw huggingface dataset:
The CHMP was concerned that study results had not shown that Efgratin was handled by the body in the same way as the reference medicine Neulasta.
Izrazil je zaskrbljenost, da rezultati študije niso dokazali, da telo zdravilo Efgratin presnavlja na enak način kot referenčno zdravilo Neulasta.
What is Efgratin?
Kaj je zdravilo Efgratin?
Efgratin was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Zdravilo Efgratin naj bi se uporabljalo za skrajšanje nevtropenije ter zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo).
‘Metastatic' means that the cancer has spread to other parts of the body.
„Metastatski“ pomeni, da se je rak razširil na druge dele telesa;
The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane on 11 January 2008.
Evropska komisija je dovoljenje za promet z zdravilom Abraxane, veljavno po vsej Evropski uniji, izdala 11. januarja 2008.
The full EPAR for Abraxane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Abraxane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It should not be interchanged with other medicines containing paclitaxel.
Ne sme se zamenjevati z drugimi zdravili, ki vsebujejo paklitaksel.
What measures are being taken to ensure the safe and effective use of Abraxane?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Abraxane?
This document is a summary of the European Public Assessment Report (EPAR) for Abraxane.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Abraxane.
For additional information, see the summary of product characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Paclitaxel has been available as a cancer medicine since 1993.
Paklitaksel je kot zdravilo proti raku na voljo od leta 1993.
A response was defined as the patient's main tumours disappearing or shrinking in size by at least 30%.
Odziv je bil opredeljen kot popolno izginotje ali zmanjšanje glavnih tumorjev bolnice za najmanj 30 %.
The recommended dose is 125 mg per square metre of body surface area once a day on days 1, 8 and 15 of each cycle.
Priporočeni odmerek je 125 mg na kvadratni meter telesne površine enkrat na dan na 1., 8. in 15. dan vsakega cikla.
The Committee decided that Abraxane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Abraxane večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The main measure of effectiveness was the percentage of patients who responded to treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so se odzvali na zdravljenje.
The most common important side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cells), gastrointestinal disorders (disorders of the digestive system), peripheral neuropathy (nerve damage including damage to the nerves in the hand and feet), arthralgia (joint pain) and myalgia (muscle pain).
Najpogostejši neželeni učinki zdravila Abraxane (opaženi pri več kot 1 bolniku od 10) so nevtropenija (nizka raven nevtrofilcev, tj. vrste belih krvničk), obolenja prebavil (obolenja prebavnega sistema), periferna nevropatija (poškodba živčevja, vključno s poškodbami živčevja dlani in stopal), artralgija (bolečine v sklepih) in mialgija (bolečine v mišicah).
Abraxane is used to treat the following cancers in adults:
Zdravilo Abraxane se uporablja za zdravljenje naslednjih vrst raka pri odraslih:
Other information about Abraxane
Druge informacije o zdravilu Abraxane
For more information about treatment with Abraxane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Abraxane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Paklitaksel prepreči fazo celične delitve, v kateri se notranji „skelet“ celice običajno razgradi, kar ji omogoči delitev.
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 Abraxane.
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.
The recommended dose is 260 mg per square metre of body surface area (calculated using the patient's height and weight).
Priporočeni odmerek je 260 mg na kvadratni meter telesne površine (izračunane na podlagi telesne višine in mase bolnika).
What benefit has Abraxane shown during the studies?
Kakšne koristi je zdravilo Abraxane izkazalo med študijami?
Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Zdravilo Abraxane učinkuje tudi na nerakave celice, kot so krvne in živčne celice, kar lahko povzroči neželene učinke.
The main measure of effectiveness was the number of patients who ‘responded' after at least five weeks of treatment.
Glavno merilo učinkovitosti je bilo število bolnic, ki so se odzvale na zdravljenje po najmanj petih tednih zdravljenja.
It contains the active substance paclitaxel attached to a human protein called albumin.
Vsebuje zdravilno učinkovino paklitaksel, ki se veže na človeško beljakovino, imenovano albumin.
Overall, in the main study, 31% of the women receiving Abraxane responded to treatment (72 out of 229), compared with 16% of the women receiving conventional paclitaxel-containing medicines (37 out of 225).
Skupno se je v glavni študiji na zdravljenje odzvalo 31 % (72 od 229) žensk, ki so prejemale zdravilo Abraxane, v primerjavi s 16 % (37 od 225) žensk, ki so prejemale standardna zdravila, ki vsebujejo paklitaksel.
The main measure of effectiveness was how long patients lived.
Glavno merilo učinkovitosti je bil čas preživetja bolnikov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abraxane, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
A risk management plan has been developed to ensure that Abraxane is used as safely and effectively as possible.
Za zagotovitev čim varnejše uporabe zdravila Abraxane je bil pripravljen načrt obvladovanja tveganj.
For metastatic breast cancer, Abraxane has been studied in one main study involving 460 women, around three-quarters of whom had received an anthracycline in the past.
Pri metastatskem raku dojke so zdravilo Abraxane proučevali v eni glavni študiji, v katero je bilo vključenih 460 žensk, od katerih jih je približno tri četrtine v preteklosti prejemalo enega od antraciklinov.
What is the risk associated with Abraxane?
Kakšna tveganja so povezana z zdravilom Abraxane?
Therefore, the company withdrew its application for the use of Abraxane as firstline treatment during the assessment of the medicine.
Zato je družba med vrednotenjem zdravila Abraxane umaknila vlogo za njegovo uporabo kot zdravilo prve izbire.
Abraxane must not be used in patients who are breast-feeding or who have low levels of neutrophils in the blood before starting treatment.
Zdravila Abraxane ne smejo uporabljati bolnice, ki dojijo, ali bolniki z nizkimi ravnmi nevtrofilcev pred začetkom zdravljenja.
• metastatic breast cancer, when the first treatment has stopped working and standard treatment including an ‘anthracycline' (another type of cancer medicine) is not suitable.
• metastatskega raka dojk, kadar je prvotno zdravljenje prenehalo delovati, standardno zdravljenje, ki vključuje antracikline (drugo vrsto zdravil proti raku), pa ni primerno.
In non-small cell lung cancer, treatment is carried out in 3-week cycles with Abraxane given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Abraxane.
Pri nedrobnoceličnem pljučnem raku se zdravljenje izvaja v tritedenskih ciklih zdravljenja, in sicer se zdravilo Abraxane daje na 1., 8. in 15. dan vsakega cikla, karboplatin pa na 1. dan cikla takoj po infundiranju zdravila Abraxane.
The recommended dose of Abraxane is 100 mg per square metre of body surface area.
Priporočeni odmerek zdravila Abraxane je 100 mg na kvadratni meter telesne površine.
Around half of the patients in the study had already received treatments for their cancer after it had become metastatic.
Približno polovica bolnic v študiji je pred tem že bila zdravljena zaradi raka, ki se je razširil na druge dele telesa.
Why has Abraxane been approved?
Zakaj je bilo zdravilo Abraxane odobreno?
Immediately after giving Abraxane gemcitabine should be given at a dose of 1000 mg per square metre of body surface area.
Takoj po dajanju zdravila Abraxane mora bolnik prejeti gemcitabin v odmerku 1 000 mg na kvadratni meter telesne površine.
Abraxane should only be given under the supervision of a specialist cancer doctor in units that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Zdravilo Abraxane se lahko daje samo pod nadzorom zdravnika specialista za rakava obolenja na oddelkih, ki so specializirani za dajanje citotoksičnih zdravil (zdravil, ki uničujejo celice).
The CHMP noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients with metastatic breast cancer whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, patients to be treated with Abraxane do not need pre-treatment with other medicines to prevent hypersensitivity reactions.
CHMP je menil, da je bilo zdravilo Abraxane pri bolnicah z metastatskih rakom dojke, pri katerih je prvotno zdravljenje prenehalo delovati, učinkovitejše od standardnih zdravil, ki vsebujejo paklitaksel, in da pri dajanju zdravila Abraxane za razliko od drugih zdravil, ki vsebujejo paklitaksel, predhodno zdravljenje z drugimi zdravili za preprečevanje preobčutljivostnih reakcij ni potrebno.
For metastatic adenocarcinoma of the pancreas, Abraxane was studied in one main study involving 861 patients who received either Abraxane in combination with gemcitabine or gemcitabine alone.
Pri metastatskem adenokarcinomu trebušne slinavke so zdravilo Abraxane proučevali v eni glavni študiji, ki je zajela 861 bolnikov in v kateri so bolniki prejemali bodisi zdravilo Abraxane v kombinaciji z gemcitabinom bodisi samo gemcitabin.
The active substance in Abraxane, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes'.
Zdravilna učinkovina zdravila Abraxane, paklitaksel, spada v skupino zdravil proti raku, imenovanih taksani.
In Abraxane, unlike conventional paclitaxel-containing medicines, the paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles'.
Za razliko od drugih zdravil, ki vsebujejo paklitaksel, je ta učinkovina v zdravilu Abraxane vezana na človeško beljakovino albumin v drobnih delcih, imenovanih nanodelci.
When looking only at the patients who were receiving their first treatment for metastatic breast cancer, there was no difference between the medicines in terms of measures of effectiveness such as the time until the disease got worse and survival.
Pri proučevanju bolnic, ki so se zaradi metastatskega raka dojk zdravile prvič, pri merilih učinkovitosti, kot sta čas do poslabšanja bolezni in čas preživetja, razlik med zdravili ni bilo.
• metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine.
• metastatskega adenokarcinoma trebušne slinavke, pri katerem se uporablja kot zdravilo prve izbire v kombinaciji z drugim zdravilom za zdravljenje raka, tj. gemcitabinom;
In addition, Abraxane given in combination with gemcitabine was shown to improve survival in patients with metastatic adenocarcinoma of the pancreas compared with treatment with gemcitabine alone and was effective in combination with carboplatin in the treatment non-small cell lung cancer.
Poleg tega je zdravilo Abraxane v kombinaciji z gemcitabinom za razliko od zdravljenja zgolj z gemcitabinom izboljšalo čas preživetja pri bolnikih z metastatskih adenokarcinomom trebušne slinavke in bilo učinkovito v kombinaciji s karboplatinom pri zdravljenju nedrobnoceličnega raka pljuč.
Patients survived for around 8.5 months on treatment with the combination of Abraxane and gemcitabine, compared with 6.7 months on gemcitabine alone.
Bolniki so ob zdravljenju s kombinacijo zdravila Abraxane in gemcitabina živeli približno 8,5 meseca v primerjavi s 6,7 meseca v skupini bolnikov, ki so prejemali samo gemcitabin.
• non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
• nedrobnoceličnega pljučnega raka, pri katerem se uporablja kot zdravilo prve izbire v kombinaciji z zdravilom proti raku, imenovanim karboplatin, pri bolnikih, pri katerih kirurški poseg ali obsevanje nista primerna.
Abraxane is given into a vein over a period of 30 minutes.
Zdravilo Abraxane se 30 minut infundira v veno.
In non-small cell lung cancer, 33% of patients receiving Abraxane and carboplatin responded to treatment compared with 25% of those receiving conventional paclitaxel and carboplatin.
Pri nedrobnoceličnem raku pljuč se je na zdravljenje odzvalo 33 % bolnikov, ki so prejemali kombinacijo zdravila Abraxane in karboplatina, v primerjavi s 25 % bolnikov, ki so prejemali kombinacijo standardnega zdravila, ki vsebuje paklitaksel, in karboplatina.
Abraxane is a powder that is made up into a suspension for infusion (drip) into a vein.
Zdravilo Abraxane je prašek za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
In metastatic breast cancer, Abraxane was more effective than conventional paclitaxel-containing medicines.
Pri metastatskem raku dojk je bilo zdravilo Abraxane učinkovitejše od standardnih zdravil, ki vsebujejo paklitaksel.
Abraxane given on its own was compared with a conventional paclitaxel-containing medicine given together with other medicines to reduce side effects.
Zdravilo Abraxane so kot samostojno zdravilo primerjali s standardnim zdravilom, ki vsebuje paklitaksel in se daje skupaj z drugimi zdravili za zmanjšanje neželenih učinkov.
In metastatic adenocarcinoma of the pancreas Abraxane is given in 4-week treatment cycles.
Pri metastatskem adenokarcinomu trebušne slinavke se zdravilo Abraxane daje v štiritedenskih ciklih zdravljenja.
In metastatic adenocarcinoma of the pancreas, Abraxane was shown to improve overall survival.
Pri metastatskem adenokarcinomu trebušne slinavke je zdravilo Abraxane izboljšalo skupni čas preživetja.
For the full list of restrictions with Abraxane, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Abraxane glejte navodilo za uporabo.
For the full list of all side effects reported with Abraxane, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Abraxane, glejte navodilo za uporabo.
For non-small cell lung cancer, the Abraxane-carboplatin combination was compared with a combination of a conventional paclitaxel-containing medicine and carboplatin in 1,052 patients.
Pri nedrobnoceličnem pljučnem raku so kombinacijo zdravila Abraxane in karboplatina pri 1 052 bolnikih primerjali s kombinacijo standardnega zdravila, ki je vsebovalo paklitaksel, in karboplatina.
In metastatic breast cancer Abraxane is given on its own every three weeks.
Pri metastatskem raku dojk se zdravilo Abraxane vsake tri tedne daje kot samostojno zdravilo.
How does Abraxane work?
Kako zdravilo Abraxane deluje?
What is Abraxane used for?
Za kaj se zdravilo Abraxane uporablja?
What is Abraxane?
Kaj je zdravilo Abraxane?
How has Abraxane been studied?
Kako je bilo zdravilo Abraxane raziskano?
How is Abraxane used?
Kako se zdravilo Abraxane uporablja?
In contrast, Abraxane was more effective than conventional paclitaxel-containing medicines in patients who had taken other treatments for metastatic breast cancer before.
Za razliko od tega pa je bilo zdravilo Abraxane pri bolnicah, ki so že bile zdravljene zaradi metastatskega raka dojke, učinkovitejše od standardnih zdravil, ki vsebujejo paklitaksel.
Treatment may be repeated for up to five consecutive days.
Zdravljenje lahko ponovite največ 5 zaporednih dni.
No data have been presented on overdoses in adult cats.
Podatki o prevelikem odmerjanju pri odraslih mačkah niso bili predloženi.
Maropitant is effective against vomiting.
Maropitant je učinkovit proti bruhanju.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Uporabljajte le v skladu z oceno koristi in tveganja odgovornega veterinarja.
Comment: Given the small vial size(s), would it not be preferable to replace these by “SC, IV"
Pripomba: Glede na to, da so viale majhne, bi jih bilo morda bolje nadomestiti s s.c., i.v.
11.1 mg For the full list of excipients, see section 6.1.
11,1 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Use only according to the benefit-risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja, saj dokončne raziskave reprodukcijske toksičnosti niso bile izvedene pri nobeni živalski vrsti.
• For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.
• Za preprečevanje perioperativne navzeje in bruhanja ter za izboljšanje okrevanja po splošni anesteziji po uporabi agonista opioidnega receptorja μ morfina.
MANUFACTURER'S BATCH NUMBER Lot:
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot:
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli neželene učinke, ki niso navedeni v tem navodilu za uporabo, ali menite, da zdravilo ni bilo učinkovito, obvestite svojega veterinarja.
For subcutaneous or intravenous use in dogs and cats.
Za subkutano ali intravensko uporabo pri psih in mačkah.
Injecting the product at refrigerated temperature may reduce pain at injection.
Injiciranje zdravila, ohlajenega na temperaturo v hladilniku, lahko zmanjša bolečino med injiciranjem.
• For the treatment of vomiting, in combination with other supportive measures.
• Za zdravljenje bruhanja, v kombinaciji z ostalimi podpornimi terapijami
Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Čeprav je bilo dokazano, da je maropitant učinkovit pri zdravljenju in preprečevanju slabosti zaradi kemoterapije, je bilo ugotovljeno, da je bolj učinkovit pri preventivi.
In cats, moderate to severe response to injection is very commonly observed (in approximately one third of cats).
Pri mačkah so zelo pogosto opazili zmeren do hud odziv na injiciranje (pri približno tretjini mačk).
This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid.
Center je sestavljen iz več možganskih jeder (area postrema, nucleus tractus solitarius, dorzalno motorično jedro vagusa), ki sprejemajo in povezujejo senzorične dražljaje centralnega in perifernega izvora in kemične dražljaje iz obtoka in cerebrospinalne tekočine.
In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
V zelo redkih primerih se lahko pojavijo anafilaktični tipi reakcij (alergijski edem, urtikarija, eritem, kolaps, dispneja, blede mukazne membrane).
Excipients: Benzyl alcohol (E1519)
Pomožne snovi: benzilalkohol (E1519)
Betadex sulfobutyl ether sodium Benzyl alcohol (E1519) Citric acid, anhydrous Sodium hydroxide Water for injections
Seznam pomožnih snovi betadeks natrijev sulfobutil eter benzilalkohol (E1519) citronska kislina, brezvodna natrijev hidroksid voda za injekcije
11.1 mg A clear, colourless to light yellow solution.
11,1 mg bistra, brezbarvna do svetlo rumena raztopina
Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraining measures may have to be applied.
Zaradi pogostega pojava prehodne bolečine med subkutanim injiciranjem bo morda potrebno žival ustrezno obvladati.
Dogs and cats.
Psi in mačke
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
Med kliničnimi raziskavami je plazemski nivo maropitanta pokazal učinkovitost 1 uro po dajanju.
Pack sizes of 1 vial of 10 ml, 20 ml, 25 ml or 50 ml.
Velikosti pakiranja: po 1 viala po 10 ml, 20 ml, 25 ml ali 50 ml.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy Beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Približno 10-odstotno povečanje QT intervala ECG so opazili v raziskavi na zdravih psih beaglih, ki so jim aplicirali 8 mg/kg, vendar pa naj tako povečanje ne bi imelo kliničnega pomena.
Vomiting is a complex process coordinated centrally by the emetic centre.
Bruhanje je kompleksen proces, ki ga uravnava center za bruhanje.
To be supplied only on veterinary prescription.
Se izdaja samo na veterinarski recept.
The elimination t1/2 following intravenous dosing was approximately 5.8 h.
Razpolovni čas izločanja t1/2 po intravenskem odmerjanju je bil približno 5,8 h.
By inhibiting the binding of substance P within the emetic centre, maropitant is effective against neural and humoral (central and peripheral) causes of vomiting.
Z inhibicijo vezave substance P v centru za bruhanje maropitant učinkuje proti nevralnim in humoralnim (centralnim in perifernim) vzrokom bruhanja.
Manufacturer responsible for batch release: Produlab Pharma B.V.
Proizvajalec zdravila, odgovoren za sproščanje serij: Produlab Pharma B.V.
In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
V primeru nenamernega stika z očmi sperite z obilo vode in poiščite zdravniško pomoč.
Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
Maropitant je antagonist nevrokinin 1 (NK1) receptorja, ki zavira vezavo substance P, tahikininskega nevropeptida.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu.
Signs of nausea in dogs including excessive salivation and lethargy might remain after treatment.
Znaki navzee pri psih, kot sta povečano slinjenje in letargija, so lahko prisotni tudi po zdravljenju.
For administration by subcutaneous injection, see also “special precautions for use in animals” (section 4.5).
Za dajanje s subkutano injekcijo glejte tudi poglavje 4.5 Posebni previdnostni ukrepi za uporabo pri živalih.