FrancophonIA/ELRC3.0 huggingface dataset:
English: − The educational tools are designed to aid physicians in optimising the benefit-risk ratio of porfimer treatment.
Slovenian: − Izobraževalna orodja so namenjena zdravnikom za optimiziranje razmerja koristi in
English: − Brief background and introduction to Barrett's oesophagus and high grade dysplasia
Slovenian: Navodila za bolnike − Kratek opis in razlaga Barretovega požiralnika ter visoke stopnje displazije
English: o Commercially available sun blocks are not effective in preventing sensitivity due to
Slovenian: o običajna komercialna sredstva za zaščito pred soncem niso učinkovita v preprečevanju preobčutljivosti.
English: − Area in card for physician to record skin type and date of injection.
Slovenian: − V bolnikovo kontrolno izkaznico vnesite tip kože in datum injiciranja zdravila.
English: • Healthcare professionals administration and monitoring guide
Slovenian: • Navodila za zdravstveno osebje za pripravo zdravila in ravnanje z njim
English: o all patients should know that UV blocking is not effective in blocking visible light o Patients should be aware of potential risk factors (skin phototype and hepatic o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Slovenian: o Bolniki morajo biti seznanjeni z možnimi nevarnostmi (fototip kože in okvare o Bolnike je treba poučiti, da se v primeru, da se med ali po zdravljenju s porfirini pojavijo fotosenzitivne reakcije, posvetujejo z zdravnikom.
English: Healthcare professional's administration and monitoring guide
Slovenian: Navodila za zdravstveno osebje za pripravo zdravila in ravnanje z njim ter izobraževalno gradivo
English: − Patients should NOT be treated with porfimer if: o they have severe hepatic disease.
Slovenian: − Bolnikov se NE sme zdraviti s porfirini, če:
English: • Prescriber guide
Slovenian: • Predstavitveno izobraževalno gradivo
English: − It is important that patients tell their doctor if they get exposed to sunlight after receiving treatment with PhotoBarr.
Slovenian: − Pomembno je, da bolniki opozorijo zdravnika, če so bili po zdravljenju s
English: − Before initiating therapy, o The patient should be screened for skin type o Patients should be aware of the long half-life of porfimer and that the compound gets o Patients should avoid being exposed to light for 60-90 days post-exposure.
Slovenian: − Bolniki morajo zdravnika pred pričetkom zdravljenja obvestiti o morebitni hudi o se v telesu zadržuje 60-90 dni po prejemu injekcije.
English: Patient alert card − The need to show this card to any doctor treating them photosensitivity are possible o Commercially available sun blocks are not effective in preventing sensitivity due to light o Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Slovenian: o se preobčutljivost na svetlobo lahko prepreči samo, če se bolnik izogiba neposredni izpostavljenosti svetlobi 90 dni po injiciranju PhotoBarra.
English: − What photodynamic therapy is
Slovenian: o se PhotoBarr aktivira z vidno svetlobo.
English: − Patients should inform their doctor before they start treatment if they have severe hepatic disease.
Slovenian: − Bolnikom je treba pojasniti, da morajo to kartico pokazati svojim lečečim zdravnikom.
English: This overview was last updated in March 2019.
Slovenian: Ta pregled je bil nazadnje posodobljen marca 2019.
English: Further information on Baycox Iron can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
Slovenian: Nadaljnje informacije o zdravilu Baycox Iron so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/baycox-iron.
English: As a result it is able to kill the parasites at all stages of their development and prevent the symptoms of coccidiosis and the spread of infection.
Slovenian: Posledično lahko parazite uniči na vseh razvojnih stopnjah ter prepreči simptome kokcidioze in širjenje okužbe.
English: It is given as a single injection into the muscle behind the ear of piglets between 48 and 72 hours old.
Slovenian: Daje se v obliki enkratne injekcije v mišico za uhljem pujskov, starih med 48 in 72 ur.
English: The European Medicines Agency decided that Baycox Iron's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Baycox Iron večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The withdrawal period for meat from pigs treated with Baycox Iron is 53 days.
Slovenian: Karenca za meso prašičev, zdravljenih z zdravilom Baycox Iron, je 53 dni.
English: Baycox Iron may be harmful for the unborn child.
Slovenian: Zdravilo Baycox Iron je lahko škodljivo za nerojene otroke.
English: Baycox Iron (toltrazuril/gleptoferron) EMA/207583/2019
Slovenian: Baycox Iron (toltrazuril/gleptoferon) EMA/207583/2019
English: Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and without additional iron, piglets raised under intensive farming conditions will develop anaemia within 10 days after birth.
Slovenian: Železo je pomembno hranilo, ki je potrebno, da hemoglobin prenaša kisik v krvi in nekatere ključne encime, brez dodatnega železa pa pujski, vzrejeni v pogojih intenzivnega kmetovanja, anemijo razvijejo v 10 dneh po rojstvu.
English: Baycox Iron received a marketing authorisation valid throughout the EU on 20 May 2019.
Slovenian: Za zdravilo Baycox Iron je bilo 20. maja 2019 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the need for iron in suckling piglets.
Slovenian: Gleptoferon se po injiciranju v mišico absorbira in presnavlja z namenom, da sprosti železo za uporabo in/ali shranjevanje, odvisno od potrebe sesnih pujskov po železu.
English: People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Baycox Iron.
Slovenian: Ljudje, ki so preobčutljivi za (alergični na) železove spojine ali toltrazuril, se morajo izogibati stiku z zdravilom Baycox Iron.
English: Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Slovenian: Toltrazuril je antiparazitik, ki vpliva na encime, ki jih paraziti kokcidije potrebujejo za tvorbo energije.
English: In a field study performed in 3 EU countries and involving 968 piglets on farms with a history of coccidiosis, a single intramuscular injection of Baycox Iron given at 3 days of age was effective in preventing iron deficiency anaemia, and reducing oocyst excretion and diarrhoea associated with coccidiosis caused by the coccidia parasite Cystoisospora suis, in comparison with giving iron only (as gleptoferron) at 3 days of age.
Slovenian: V terenski študiji, ki je bila izvedena v treh državah članicah EU in je vključevala 968 pujskov na farmah, na katerih se je v preteklosti že pojavila parazitska okužba kokcidioza, se je izkazalo, da je enkratna intramuskularna injekcija zdravila Baycox Iron, ki se daje pri starosti tri dni, učinkovita pri preprečevanju anemije zaradi pomanjkanja železa ter zmanjšanju izločanja oocist in driske, povezane s kokcidiozo, ki jo povzroča parazit Cystoisospora suis, v primerjavi z dajanjem samo železa (v obliki gleptoferona) pri starosti tri dni.
English: The most common side effects with Baycox Iron (which may affect up to 1 in 10 piglets) are short-lived tissue discolouration and slight swelling at the injection site.
Slovenian: Najpogostejši neželeni učinki zdravila Baycox Iron (ki se lahko pojavijo pri največ 1 od 10 pujskov) so kratkotrajno razbarvanje tkiva in blaga oteklina na mestu injiciranja.
English: Baycox Iron must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Slovenian: Zdravilo Baycox Iron se ne sme dajati pujskom, pri katerih obstaja sum pomanjkanja vitamina E ali selena.
English: For more information about using Baycox Iron, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Baycox Iron glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: Other information about Baycox Iron
Slovenian: Druge informacije o zdravilu Baycox Iron
English: Baycox Iron is also used to reduce spread of the infection through passage of oocysts in faeces, and at the same time to prevent iron deficiency anaemia due to the limited iron reserves of new-born piglets, low iron content of milk and high growth rate of suckling piglets.
Slovenian: Zdravilo Baycox Iron se uporablja tudi za zmanjšanje širjenja okužbe prek oocist v iztrebkih in sočasno za preprečevanje anemije zaradi omejenih rezerv železa pri novorojenih pujskih, nizke vsebnosti železa v mleku in hitre rasti sesnih pujskov.
English: It is used in young piglets on farms which have been affected in the past by the parasitic infection coccidiosis to prevent diarrhoea caused by a new coccidiosis infection.
Slovenian: Uporablja se pri pujskih na farmah, na katerih se je v preteklosti že pojavila parazitska okužba kokcidioza, za preprečevanje driske, ki jo povzroči nova okužba s kokcidiji.
English: Baycox Iron is a veterinary medicine.
Slovenian: Baycox Iron je zdravilo za uporabo v veterinarski medicini.
English: Baycox Iron (toltrazuril/gleptoferron)
Slovenian: Baycox Iron (toltrazuril/gleptoferon)
English: Why is Baycox Iron authorised in the EU?
Slovenian: Zakaj je zdravilo Baycox Iron odobreno v EU?
English: Infected piglets shed disease spores (oocysts) in their faeces that can spread the infection.
Slovenian: Okuženi pujski z iztrebki izločajo bolezenske spore (oociste), ki lahko širijo okužbo.
English: Coccidiosis is a disease of the gut which results in reduced growth due to diarrhoea.
Slovenian: Kokcidioza je črevesna bolezen, za katero je značilen zastoj rasti zaradi driske.
English: For the full list of side effects and restrictions of Baycox Iron, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Baycox Iron glejte navodilo za uporabo.
English: An overview of Baycox Iron and why it is authorised in the EU
Slovenian: Pregled zdravila Baycox Iron in zakaj je odobreno v EU
English: What is Baycox Iron and what is it used for?
Slovenian: Kaj je zdravilo Baycox Iron in za kaj se uporablja?
English: Baycox Iron is available as an injection and can only be obtained with a prescription.
Slovenian: Zdravilo Baycox Iron je na voljo v obliki injekcije, njegovo predpisovanje in izdaja pa je le na recept.
English: What are the risks associated with Baycox Iron?
Slovenian: Kakšna tveganja so povezana z zdravilom Baycox Iron?
English: What benefits of Baycox Iron have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Baycox Iron izkazalo v študijah?
English: The other active substance in Baycox Iron, gleptoferron, is an iron-containing compound.
Slovenian: Druga učinkovina v zdravilu Baycox Iron, gleptoferon, je spojina, ki vsebuje železo.
English: Baycox Iron contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Slovenian: Zdravilo Baycox Iron vsebuje učinkovini toltrazuril in gleptoferon (spojina, ki vsebuje železo).
English: How does Baycox Iron work?
Slovenian: Kako zdravilo Baycox Iron deluje?
English: How is Baycox Iron used?
Slovenian: Kako se zdravilo Baycox Iron uporablja?
English: Applicant company name, address
Slovenian: Ime, naslov podjetja predlagatelja
English: Mentocaína Spray 8.75 mg/dose Oromucosal spray, solution
Slovenian: Mentocaína Spray 8,75 mg/ odmerek
English: Check with your doctor.
Slovenian: Posvetujte se s svojim zdravnikom.
English: Unopened vial: 2 years.
Slovenian: Neodprta viala: 2 leti.
English: More than half of the responses were apparent after the first three cycles of treatment.
Slovenian: Več kot pol odzivov je bilo očitnih po prvih treh krogih zdravljenja.
English: • Ringing in your ears
Slovenian: • zvonjenje v ušes
English: Each infusion contains up to 21 g of alcohol.
Slovenian: Vsaka infuzija zdravila vsebuje do 21 g alkohola.
English: These agents are used to treat cancer.
Slovenian: Ta zdravila se uporabljajo za zdravljenje raka.
English: • Bad taste in your mouth
Slovenian: • slab okus v ustih
English: • are taking other medicines that you have bought for yourself without a prescription.
Slovenian: • jemljete druga zdravila, ki ste jih kupili brez recepta.
English: The use of gloves, goggles and protective clothing is recommended.
Slovenian: Priporočljiva je uporaba rokavic, zaščitnih očal in oblek.
English: For each of these parameters, the increases were severe in 1% of cases.
Slovenian: Do hujšega povečanja pri vsakem od teh parametrov je prišlo v 1 % primerov.
English: • Painful sensation in the body
Slovenian: • boleč občutek v telesu
English: 19 % of patients had severe neutropenia for > 7 days.
Slovenian: 19 % bolnikov je imelo hudo nevtropenijo > 7 dni.
English: Date of first authorisation: 19th July 1999.
Slovenian: Datum pridobitve dovoljenja za promet: 19. julij 1999.
English: Patients should be observed closely during the initial cycles of treatment.
Slovenian: Bolnike je potrebno v začetnih ciklih zdravljenja natančno opazovati.
English: This subgroup of patients is considered to constitute the core efficacy population.
Slovenian: Ta podskupina bolnikov predstavlja glavno populacijo, pri kateri je bila učinkovitost največja.
English: • Paxene is not recommended for use in children and adolescents under 18 years.
Slovenian: • Zdravila Paxene ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: In the study, the majority of patients were administered granulocyte colony stimulating factor (G-CSF).
Slovenian: V študiji so večini bolnikov dali granulocitne kolonije stimulirajoči faktor (G-CSF).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki predstavljeni v padajoči resnosti.
English: Dispose of any remaining contents after first use.
Slovenian: Preostalo vsebino zavrzite po prvi uporabi.
English: Limited efficacy data supports this indication (see section 5.1).
Slovenian: Omejeni podatki o učinkovitosti podpirajo to indikacijo (glejte poglavje 5.1).
English: Based on in vitro studies, the degree of plasma protein binding has been reported to range from 88 to 98 %.
Slovenian: Na osnovi študij in vitro so poročali, da je stopnja vezave na plazemske beljakovine med 88 in 98 %.
English: Gastrointestinal
Slovenian: Gastrointestinalni
English: Date of latest renewal: 19th July 2009
Slovenian: Datum podaljšanja: 19. julij 2009.
English: Infections and infestations
Slovenian: Infekcije in infestacije
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Slovenian: Količina alkohola v tem zdravilu lahko spremeni učinek drugih zdravil.
English: If necessary, your doctor will adjust the dosage during the treatment.
Slovenian: Vaš zdravnik bo med zdravljenjem po potrebi prilagodil odmerek.
English: The carcinogenic potential of paclitaxel has not been studied.
Slovenian: Karcinogenega potenciala paklitaksela niso preučevali.
English: • Eating disorders including anorexia
Slovenian: • motnje prehranjevanja vključno z anoreksijo
English: If you see another doctor or visit a hospital, remember to tell them what medicines you are taking.
Slovenian: Če boste obiskali drugega zdravnika ali bolnišnico, mu morate povedati, katera zdravila prejemate.
English: The median time to progression in the core population was 468 days (95 % CI 257-NE).
Slovenian: Srednja vrednost do stopnjevanja pri glavni populaciji je bila 468 dni (95 % CI 257-NE).
English: Concurrent, serious, uncontrolled infections.
Slovenian: Sočasne, resne, nenadzorovane okužbe.
English: As the AIDS-KS population is very specific, safety data from a clinical study of 107 AIDS-KS patients are presented separately at the end of this section.
Slovenian: Populacija bolnikov z AIDS-KS je zelo specifična, zato so podatki o varnosti iz klinične študije 107 bolnikov z AIDS-KS predstavljeni ločeno na koncu tega poglavja.
English: • Loosening of finger and toe nails - you should wear protection on your feet and hands when exposed to the sun
Slovenian: • zrahljanje nohtov na rokah in nogah - nositi morate zaščito rok in nog, če jih izpostavljate soncu
English: • The levels of some enzymes in your blood might rise
Slovenian: • v krvi se lahko povečajo ravni nekaterih encimov
English: To help prevent allergic reactions occurring while you are receiving your infusion you will be given medication before your treatment starts.
Slovenian: Da bi preprečili alergijske reakcije, ki se lahko pojavijo med dajanjem infuzije, boste pred začetkom zdravljenja prejeli nekatera zdravila.
English: Pharmacotherapeutic group: taxanes, ATC code: L01CD01.
Slovenian: Farmakoterapevtska skupina: taksani, oznaka ATC: L01C D01
English: Like other genotoxic cytostatics, paclitaxel can have genotoxic effects.
Slovenian: Podobno drugim genotoksičnim citostatikom, ima lahko paclitaxel genotoksične učinke.
English: This reaction should be considered in the differential diagnosis of cases of severe or persistent diarrhoea occurring during or shortly after treatment with paclitaxel.
Slovenian: Omenjeno reakcijo je treba upoštevati pri diferencialni diagnostiki primerov s hudo ali perzistirajočo diarejo, ki se pojavi med ali le kratek čas po zdravljenju s paklitakselom.
English: Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubular network that is essential for vital interphase and mitotic cellular functions.
Slovenian: Zaradi stabilizacije je zavrta normalna dinamična reorganizacija mreže mikrotubulov, ki je bistvenega pomena pri ključnih celičnih funkcijah v interfazi in mitozi.
English: The amounts (dose) of Paxene you will be given will be worked out depending on your body surface area in square meters (m2) and will also take into account the results of your blood tests and your medical condition.
Slovenian: Količino (odmerek) zdravila Paxene, ki jo boste prejeli bodo določili glede na vašo telesno površino, izraženo v kvadratnih metrih (m2), in ob upoštevanju rezultatov krvnih preiskav ter vašega zdravstvenega stanja.
English: The amount of alcohol in this medicine may alter the effects of other medicines and should be taken into account in patients with liver disease or epilepsy.
Slovenian: Količina alkohola v tem zdravilu lahko spremeni učinek drugih zdravil, kar je treba upoštevati pri zdravnikih z obolelimi jetri ali z epilepsijo.
English: Of the 107 patients, 63 patients were considered resistant to liposomal anthracyclines.
Slovenian: Od 107 je bilo 63 bolnikov odpornih proti liposomskim antraciklinom.
English: Further data on the potential of drug interactions between paclitaxel and other CYP 3A4 substrates/inhibitors are limited.
Slovenian: Nadaljnji podatki o morebitnih interakcijah med paklitakselom in drugimi substrati/zaviralci CYP 3A4 so omejeni.
English: • If you are taking other medicines which could interact with paclitaxel (see Using other medicines).
Slovenian: • Če jemljete druga zdravila, ki bi lahko medsebojno delovala s paklitakselom (glejte Uporaba drugih zdravil).
English: In spite of this high protein binding, paclitaxel is widely distributed to tissues.
Slovenian: Kljub visoki vezanosti na beljakovine se paklitaksel široko porazdeljuje v tkiva.
English: The other most commonly reported nervous system disorder is somnolence, which affected 14 % of patients.
Slovenian: Druga bolezen živčnega sistema o kateri se najpogostejše poroča je zaspanost, ki je prizadela 14 % bolnic.
English: • Acute leukaemia (blood cancer)
Slovenian: • akutna levkemija (krvni rak)
English: Your concentrate for solution for infusion will be kept in the pharmacy and they will prepare it, ready to be given by the doctor or nurse.
Slovenian: Vaš koncentrat za raztopino za infundiranje bodo shranjevali v lekarni in ga zdravniku ali medicinski sestri pripravili za uporabo.
English: Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
Slovenian: Obstoječe nevropatije, ki so posledica prejšnjih zdravljenj, niso kontraindikacija za zdravljenje s paklitakselom.
English: Half to one hour before your infusion you will be given two different types of injection (an antihistamine and an H2 antagonist).
Slovenian: Pol ure do eno uro pred infuzijo boste prejeli še dve vrsti injekcij (antihistaminik in antagonist receptorjev H2).
English: Clear, colourless to slightly yellow, viscous solution.
Slovenian: Bistra, brezbarvna do rahlo rumena viskozna tekočina.
English: The incidence of Grade 4 neutropenia lasting 7 days or more was 22 %.
Slovenian: Incidenca nevtropenije 4. stopnje, ki je trajala sedem dni ali več, je bila 22-odstotna.
English: Neutropenia resolved in 35 days in all patients who were followed.
Slovenian: Nevtropenija je pri vseh zdravljenih bolnikih izginila v 35 dneh.
English: Important information about some of the ingredients of Paxene
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Paxene
English: Red cell transfusions were required in 21 % of patients.
Slovenian: Pri 21 % bolnikov je bila potrebna transfuzija rdečih krvnih celic.
English: In addition, paclitaxel induces bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Slovenian: Poleg tega paklitaksel inducira nastanek snopov mikrotubulov v celotnem celičnem ciklu ter oblikovanje multiplih aster mikrotubulov v času mitoze.
English: London E16 2QJ United Kingdom.
Slovenian: London E16 2QJ Velika Britanija.
English: Your concentrate for solution for infusion will be diluted and given slowly into a vein over about 3 hours unless otherwise stated.
Slovenian: Koncentrat za raztopino za infundiranje bodo najprej razredčili in vam ga nato v 3 urah počasi dali v veno, razen če ni drugače navedeno.
English: - Keep this leaflet safe as you may need to read it again.
Slovenian: Morda ga boste želeli ponovno prebrati.
English: The results obtained with Paxene are closely similar to those of published paclitaxel Phase III trials.
Slovenian: Rezultati, dobljeni pri uporabi zdravila Paxene, so zelo podobni objavljenim iz III. faze preskušanj paklitaksela.
English: Since elimination of doxorubicin and its active metabolites may be reduced when paclitaxel and doxorubicin are used in combination, paclitaxel should be administered 24 hours after doxorubicin.
Slovenian: Ker se eliminacija doksorubicina in njegovih aktivnih metabolitov lahko zmanjša, kadar se paklitaksel in doksorubicin uporabljata skupaj, naj se paklitaksel uporabi šele 24 ur po doksorubicinu.
English: Arthralgia was reported in 32 % of all patients (5 % severe) and myalgia in 47 % (6 % severe).
Slovenian: O artralgiji so poročali pri 32 % vseh bolnikov (5 % huda) in o mijalgiji pri 47 % (6 % huda).
English: Paraesthesia was observed in 48 % of patients.
Slovenian: Parestezijo so opazili pri 48 % bolnikov.
English: Paclitaxel, particularly in combination with radiation of the lung and/or gemcitabine, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis.
Slovenian: Paklitaksel, zlasti v kombinaciji z obsevanjem pljuč in/ali gemcitabinom, ne glede na časovno zaporedje, lahko prispeva k razvoju intersticialnega pnevmonitisa.
English: • are taking ritonavir, nelfinavir, efavirenz, nevirapine (for the treatment of AIDS) or any other prescribed medicines for your condition;
Slovenian: • jemljete ritonavir, nelfinavir, efavirenz, nevirapin (za zdravljenje AIDS-a) ali katerokoli drugo zdravilo, ki so vam ga predpisali za vašo bolezen;
English: The disposition of paclitaxel is non-linear (concentration dependent) as the systemic exposure increases more than expected following an increase in dosage.
Slovenian: Izpostavljenost paklitakselu je nelinearna (odvisna od koncentracije), ker se s povečevanjem odmerka sistemska izpostavljenost poveča bolj, kot bi pričakovali.