FrancophonIA/ELRC3.0 huggingface dataset:
English: During the 25 weeks of treatment, 35% of patients given Buvidal had a negative urine test, compared with 28% of patients taking the comparator tablets.
Slovenian: Med 25-tedenskim zdravljenjem je bil pri 35 % bolnikov, ki so prejemali zdravilo Buvidal, test urina negativen, v primerjavi z 28 % bolnikov, ki so jemali primerjalne tablete.
English: As for all medicines, data on the use of Buvidal are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Buvidal stalno spremljajo.
English: Why is Buvidal authorised in the EU?
Slovenian: Zakaj je zdravilo Buvidal odobreno v EU?
English: The main measure of effectiveness was based on the number of urine samples that tested negative for opioids.
Slovenian: Glavno merilo učinkovitosti je bilo število vzorcev urina, ki so bili negativni na opioide.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Buvidal have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Buvidal upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Buvidal is given in a different way.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako učinkovino, vendar se daje drugače.
English: It can only be obtained with a prescription and can only be given by a healthcare professional.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, daje pa ga lahko samo strokovni zdravstveni delavec.
English: Weekly or monthly injections with Buvidal would offer an additional option for managing the condition.
Slovenian: Tedensko ali mesečno injiciranje zdravila Buvidal bi nudilo dodatno možnost za obvladovanje stanja.
English: Side effects reported with Buvidal are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Buvidal, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The first dose of Buvidal is given when the patient shows clear signs of withdrawal.
Slovenian: Prvi odmerek zdravila Buvidal se da, ko bolnik kaže jasne znake odtegnitve.
English: What benefits of Buvidal have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Buvidal izkazalo v študijah?
English: What are the risks associated with Buvidal?
Slovenian: Kakšna tveganja so povezana z zdravilom Buvidal?
English: Other information about Buvidal
Slovenian: Druge informacije o zdravilu Buvidal
English: Buvidal must not be used in patients with severe respiratory insufficiency (inability to breathe properly) and severe liver problems and in patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Slovenian: Zdravilo Buvidal se ne sme uporabljati pri bolnikih s hudo respiratorno insuficienco (dihalno stisko) in hudimi težavami z jetri ter pri bolnikih, ki so pod vplivom alkohola ali imajo simptome odtegnitve alkohola.
English: The most common side effects with buprenorphine (which may affect more than 1 in 10 people) are headache, nausea (feeling sick), hyperhidrosis (excessive sweating), insomnia (difficulty sleeping), drug withdrawal syndrome and pain.
Slovenian: Najpogostejši neželeni učinki buprenorfina (ki lahko prizadenejo več kot 1 osebo od 10) so glavobol, navzeja (slabost), hiperhidroza (pretirano znojenje), nespečnost, odtegnitveni sindrom in bolečine.
English: What is Buvidal and what is it used for?
Slovenian: Kaj je zdravilo Buvidal in za kaj se uporablja?
English: The dose of Buvidal can be adjusted and patients can be switched between weekly and monthly injections according to the patient's need and the judgement of the treating doctor.
Slovenian: Odmerek zdravila Buvidal se lahko prilagodi, bolniki pa lahko prehajajo s tedenskih na mesečna injiciranja in obratno v skladu s potrebo bolnika in presojo lečečega zdravnika.
English: For patients dependent on short-acting opioids (e.g. morphine or heroin), the first dose is given at least 6 hours after the patient last used an opioid.
Slovenian: Bolnikom, ki so odvisni od kratkotrajno delujočih opioidov (npr. morfina ali heroina), se prvi odmerek da najmanj šest ur po zadnji uporabi opioida.
English: A study involving 428 patients with opioid dependence showed that Buvidal was effective at reducing patients' intake of opioid drugs.
Slovenian: Študija, v katero je bilo vključenih 428 bolnikov, odvisnih od opioidov, je pokazala, da je bilo zdravilo Buvidal učinkovito pri zmanjševanju vnosa opioidov.
English: Buvidal is a medicine used to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Slovenian: Buvidal je zdravilo, ki se uporablja za zdravljenje odvisnosti od opioidov (narkotikov), kot sta heroin in morfin.
English: For more information about using Buvidal, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Buvidal glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: These patients should be started on weekly doses of Buvidal before moving to monthly injections.
Slovenian: Pri teh bolnikih je treba začeti s tedenskimi odmerki zdravila Buvidal, preden preidejo na mesečno injiciranje.
English: The active substance in Buvidal, buprenorphine, is a partial opioid agonist (it acts like an opioid drug but less powerfully).
Slovenian: Učinkovina zdravila Buvidal, buprenorfin, je delni opioidni agonist (deluje kot opioid, vendar ni tako močan).
English: Buvidal is given as an injection under the skin, either once a week or once a month.
Slovenian: Zdravilo Buvidal se injicira pod kožo enkrat tedensko ali enkrat mesečno.
English: Buvidal contains the active substance buprenorphine and is a ‘hybrid medicine'.
Slovenian: Zdravilo Buvidal vsebuje učinkovino buprenorfin in je „hibridno zdravilo“.
English: Patients who have never taken buprenorphine before should be given a 4 mg buprenorphine tablet and be monitored for one hour before being given Buvidal, to make sure they tolerate the medicine.
Slovenian: Bolniki, ki pred tem še niso jemali buprenorfina, prejmejo 4-miligramsko tableto buprenorfina, nato pa se jih, preden se jim da zdravilo Buvidal, opazuje eno uro, da se prepriča ali zdravilo prenašajo.
English: The European Medicines Agency concluded that Buvidal was at least as effective as buprenorphine tablets at treating opioid dependence.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo zdravilo Buvidal pri zdravljenju odvisnosti od opioidov vsaj tako učinkovito kot tablete buprenorfina.
English: While Subutex is available as sublingual tablets (tablets to be placed under the tongue), Buvidal is available as a solution for injection under the skin.
Slovenian: Zdravilo Subutex je na voljo v obliki podjezičnih tablet (tablet, ki se položijo pod jezik), zdravilo Buvidal pa kot raztopina za injiciranje pod kožo.
English: The reference medicine for Buvidal is Subutex.
Slovenian: Referenčno zdravilo za zdravilo Buvidal je zdravilo Subutex.
English: Patients who have taken buprenorphine before may be switched directly to weekly or monthly Buvidal injections.
Slovenian: Bolniki, ki so pred tem že jemali buprenorfin, lahko neposredno preidejo na tedensko ali mesečno injiciranje zdravila Buvidal.
English: How is Buvidal used?
Slovenian: Kako se zdravilo Buvidal uporablja?
English: In this study, Buvidal was compared with sublingual tablets containing buprenorphine and another medicine, naloxone (which is used to prevent misuse).
Slovenian: V tej študiji so zdravilo Buvidal primerjali s podjezičnimi tabletami, ki vsebujejo buprenorfin in nalokson (drugo zdravilo, ki se uporablja za preprečevanje zlorabe narkotikov).
English: For patients dependent on long-acting opioids (e.g. methadone), the dose of methadone is reduced to below 30 mg per day before starting Buvidal.
Slovenian: Bolnikom, ki so odvisni od dolgotrajno delujočih opioidov (npr. metadona), se pred začetkom zdravljenja z zdravilom Buvidal, odmerek metadona zmanjša na manj kot 30 mg na dan. Prvi odmerek zdravila Buvidal se da najmanj 24 ur po zadnji uporabi metadona.
English: How does Buvidal work?
Slovenian: Kako zdravilo Buvidal deluje?
English: For the full list of side effects and restrictions of Buvidal, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Buvidal glejte navodilo za uporabo.
English: EU/1/18/1292/001 Apealea
Slovenian: EU/1/18/1292/001 Zdravilo Apealea
English: Intravenous use vial (glass)
Slovenian: Prašek za raztopino za infundiranje intravenska uporaba viala (steklena)
English: These measures will help protect the environment.
Slovenian: Ti ukrepi bodo pomagali varovati okolje.
English: Your doctor will explain this to you.
Slovenian: Vaš zdravnik vam bo to razložil.
English: Are you pregnant, or do you think you might be pregnant?
Slovenian: • Ste noseči, ali pa mislite da bi lahko bili noseči?
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti se nanaša na zadnji dan tistega meseca.
English: These reactions have caused death in some cases.
Slovenian: V nekaterih primerih so te reakcije povzročile smrt.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika bi moral biti izdelek uporabljen takoj.
English: It may continue for a total of 7 to 14 days.
Slovenian: • Lahko se nadaljuje do skupno 7 do 14 dni.
English: Species for which acquired resistance may be a problem
Slovenian: Vrste pri katerih pridobljena odpornost lahko predstavlja težavo
English: Thus it is only suitable for treating some types of infection.
Slovenian: Tako je primeren le za zdravljenje nekaterih vrst okužb.
English: In this section undesirable effects are defined as follows:
Slovenian: V tem odstavku so neželeni učinki definirani takole:
English: If this happens, do not drive or use machines.
Slovenian: Če se to zgodi ne vozite in ne upravljajte s stroji.
English: It may harm them, even if their symptoms are the same as yours.
Slovenian: Njim lahko celo škoduje, četudi imajo bolezenske znake, ki so podobni vašim.
English: The following information is intended for medical or healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo medicinskemu osebju oziroma strokovnjakom s področja varovanja zdravja:
English: It is important that this medicine is used in the prescribed course which should not be interrupted only because you feel well again.
Slovenian: Pomembno je, da se to zdravilo uporablja predpisano obdobje, ki se ga ne sme prekiniti samo zato, ker se zopet počutite bolje.
English: It has not been shown to possess any mutagenic activity.
Slovenian: Niso ugotovili, da bi imel kakršnokoli mutageno delovanje.
English: Ask your pharmacist how to dispose of medicines no longer required.
Slovenian: Vprašajte svojega farmacevta na kakšen način je treba odstranjevati zdravila, ki jih nič več ne potrebujete.
English: See also section "Principal chemical intolerances“.
Slovenian: Glejte tudi poglavje "Najpomembnejše kemične inkompatibilnosti".
English: Adults ≥ 17 years
Slovenian: Odrasli ≥ 17 let
English: Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary.
Slovenian: Čeprav za to zdravilo ni znano, da bi škodovalo nerojenemu otroku, se ga lahko noseči ženski daje le, če je to resnično potrebno.
English: This disorder is rare in adults (see below).
Slovenian: Ta motnja je pri odraslih redka (glejte spodaj).
English: and 0.25 µg/ml for Neisseria gonorrhoea.
Slovenian: in 0.25 µg/ml za Neisseria gonorrhoea.
English: This is especially if these other medicines also affect how well kidneys work.
Slovenian: To je še posebej izrazito, če ta druga zdravila vplivajo tudi na to, kako dobro ledvica delujejo.
English: Moreover half life is longer than in adults.
Slovenian: Poleg tega je razpolovni čas daljši kot pri odraslih.
English: Controlled and validated aseptic conditions have to be observed.
Slovenian: Držati se je treba nadzorovanih in aseptičnih razmer.
English: See also the information included in section 6.2.
Slovenian: Glejte tudi podatke, ki so vključeni v poglavje 6.2.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE JE POTREBNO
English: C.F. Tietgens Boulevard 40 5220 Odense SØ, Denmark
Slovenian: C.F. Tietgens Boulevard 40 5220 Odense SØ, Danska
English: For elderly patients the dosage recommendations are the same as for adults - without modification.
Slovenian: Pri starejših bolnikih veljajo enaka priporočila kar zadeva odmerjanje zdravila kot pri odraslih - brez prilagajanja.
English: Section 4.8
Slovenian: Poglavje 4.8
English: Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
Slovenian: Upoštevati je treba uradne lokalne smernice glede ustrezne uporabe protimikrobnih sredstev.
English: One single administration is usually sufficient.
Slovenian: En sam odmerek običajno zadostuje.
English: Talk to your doctor if you have been told to limit the amount of sodium in your diet.
Slovenian: Pogovorite se s svojim zdravnikom, če so vam rekli, da morate omejiti množino natrija v svoji prehrani.
English: If the treatment course is stopped too early the infection may start up again.
Slovenian: Če obdobje zdravljenja prehitro zaključite, se okužba lahko ponovi.
English: Laboratory-diagnostic tests
Slovenian: Laboratorijsko-diagnostični testi
English: Sandoz Limited Woolmer way Bordon, Hants, GU35 9QE United Kingdom
Slovenian: Sandoz Limited Woolmer way Bordon, Hants, GU35 9QE Velika Britanija
English: The CHMP therefore agreed to recommend the following dosage recommendation:
Slovenian: CHMP torej soglaša, da se priporoči naslednje odmerjanje:
English: If you are having a blood test for any reason, tell the person who is taking your blood sample that you are taking this medicine as it may affect your result.
Slovenian: Če pri vas iz kateregakoli razloga opravljajo preiskavo krvi, osebi, ki jemlje vzorec vaše krvi povejte, da jemljete to zdravilo, kajti to zdravilo lahko vpliva na rezultat preiskave.
English: These types of antibiotic are similar to penicillin.
Slovenian: Antibiotiki te vrste so podobni penicilinu.
English: The possibility of sensitisation should be borne in mind.
Slovenian: Zavedati se je treba možnosti pojava preobčutljivosti.
English: (Please note the manufacturer's information on the risks of lidocaine hydrochloride in the relevant information documents on the respective lidocaine preparations used).
Slovenian: (Prosimo, da upoštevate podatke izdelovalca kar zadeva tveganja, povezana z lidokainijevim kloridom, v ustreznih dokumentih s podatki, ki se nanašajo na posamezne uporabljene pripravke z lidokainom).
English: Take the medicine with you in the carton, so that the staff will know exactly what has been used.
Slovenian: S seboj vzemite zdravilo v škatli, tako da bo osebje natančno vedelo, katero zdravilo ste vzeli.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: POSEBNI PREVIDNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH MATERIALOV, KI IZHAJAJO IZ TAKIH ZDRAVIL, ČE JE PRIMERNO
English: The mean volume of distribution in healthy adults is 0.13 l/kg.
Slovenian: Povprečni porazdelitveni volumen pri zdravih odraslih znaša 0,13 l/kg.
English: The normal duration of therapy depends on the characteristics of the infection.
Slovenian: Običajno trajanje zdravljenja je odvisno od značilnosti okužbe.
English: This is because small amounts of it enter the milk and thus the breast-fed infant.
Slovenian: To pa zato, ker se majhne množine zdravila pojavijo v mleku in s tem v dojenem otroku.
English: • sepsis
Slovenian: • sepsa
English: This medicine should not be given to women who are breastfeeding.
Slovenian: Tega zdravila se ne sme dajati ženskam, ki dojijo.
English: The usual doses are:
Slovenian: Običajni odmerki so:
English: It is important to tell the doctor that you are taking this medicine if you have to have any of these tests.
Slovenian: Pomembno je, da svojemu zdravniku poveste, da jemljete to zdravilo, če bi morali pri vas opraviti katero izmed teh preiskav.
English: Minor prolongation in the prothrombin time has been described.
Slovenian: Opisano je bilo manjše podaljšanje protrombinskega časa.
English: There are many medicines that can do this, so you should check with your doctor or pharmacist before taking this medicine.
Slovenian: Obstaja veliko zdravil, ki lahko to naredijo, tako da morate s svojim zdravnikom ali farmacevtom pred jemanjem tega zdravila to preveriti.
English: Superinfections with non- susceptible micro-organisms.
Slovenian: Superinfekcije z neobčutljivimi mikroorganizmi.
English: In this respect, there may be some cross-reactivity with penicillins.
Slovenian: V tem pogledu bi lahko bila prisotna kakšna navzkrižna reaktivnost s penicilini.
English: Usually only one dose is given
Slovenian: Običajno se da samo en odmerek.
English: An injection into the blood vessels must be strictly avoided.
Slovenian: Strogo se je treba izogibati injiciranju v krvno žilo.
English: Medicines should not be disposed via wastewater or household waste.
Slovenian: Zdravil se ne sme odmetavati v odpadno vodo ali gospodinjske odpadke.
English: Its effectiveness in a number of clinically relevant infections has been established during more than ten years of therapeutical use.
Slovenian: Njegova učinkovitost proti velikem številu klinično pomembnih okužb je bila potrjena v več kot desetih letih uporabe.
English: Dosage recommendations for special indications should be taken into account.
Slovenian: Upoštevati je treba priporočila glede odmerjanja pri posebnih indikacijah.
English: During the first few weeks of life the ability to clear ceftriaxone changes although the exact time point at which this occurs has not been truly determined.
Slovenian: V prvih nekaj tednih se sposobnost očistka ceftriaksona spremeni, vendar natančen čas, ko se to zgodi, ni bil določen.
English: These opacities usually occurred only after administration of higher doses than the recommended standard doses.
Slovenian: Te motnosti so se običajno pojavile samo po dajanju odmerkov, ki so bili večji od priporočenih standardnih odmerkov.
English: It also depends on your weight and how your kidneys are working.
Slovenian: Odvisen je tudi od vaše telesne mase in od tega, kako delujejo vaše ledvice.
English: In the rare cases in which the precipitates are accompanied by clinical symptoms such as pain, symptomatic measures are recommended.
Slovenian: V redkih primerih pri katerih usedline spremljajo klinični simptomi kot je bolečina, se priporočajo simptomatski ukrepi.
English: These undesirable effects are mostly mild and frequently subside during, otherwise after discontinuation of therapy.
Slovenian: Ti neželeni učinki so večinoma blagi in pogosto izginejo med samim zdravljenjem, drugače pa po prenehanju zdravljenja.
English: No case of overdose has been reported.
Slovenian: Niso poročali o nobenem primeru prevelikega odmerjanja.
English: If you do not feel well at the end of the prescribed treatment course or even feel worse during treatment you should talk to your doctor.
Slovenian: Če se ob koncu predpisanega obdobja zdravljenja ne počutite dobro, ali pa se med zdravljenjem počutite celo slabše, se morate o tem pogovoriti s svojim zdravnikom.
English: When given before an operation, the normal daily dose is given 30-90 minutes before the operation.
Slovenian: • Kadar se daje pred operacijo, se običajen dnevni odmerek da 30 do 90 minut pred operacijo.
English: • bacterial meningitis
Slovenian: • bakterijski meningitis
English: This solution has to be transferred into a suitable infusion bag.
Slovenian: Raztopino je treba prenesti v primerno infuzijsko vrečko.
English: Unopened: 2 years.
Slovenian: Neodprto zdravilo: 2 leti.
English: Commonly susceptible species
Slovenian: Običajno občutljive vrste
English: This can be a sign of a serious bowel inflammation (called “pseudomembranous colitis”) that can happen after taking antibiotics.
Slovenian: To je lahko znak hudega vnetja črevesja (imenovano "psevdomembranski kolitis"), ki se lahko pojavi po jemanju antibiotikov.
English: Despite the limited and somehow old scientific data, intensive search by the applicant did not reveal scientific evidence which makes it necessary to change these dosage recommendations which are authorised since years without safety concerns in several Member States.
Slovenian: Temeljite raziskave kljub omejenim in nekoliko zastarelim znanstvenim podatkom, ki jih je opravil vlagatelj, niso dale znanstvenih dokazov, zaradi katerih bi bilo nujno spremeniti režim odmerjanja, ki je bil več let brez pomislekov o varnosti odobren v več državah članicah.
English: The dose your doctor gives depends on the type of infection and how bad the infection is.
Slovenian: Odmerek, ki vam ga vaš zdravnik da, je odvisen od vrste okužbe in od tega, kako huda je okužba.
English: The length of treatment is usually at least 2 days beyond the normalisation of body temperature.
Slovenian: • Dolžina zdravljenja običajno znaša najmanj dva dneva po normalizaciji telesne temperature.
English: This may affect your ability to drive or operate machinery.
Slovenian: To bi lahko vplivalo na vašo sposobnost za vožnjo in upravljanje s stroji.
English: Principal chemical intolerances
Slovenian: Najpomembnejše kemične inkompatibilnosti
English: The urine concentrations are 5-10 times higher than those found in the plasma.
Slovenian: Koncentracije v seču so 5 do 10-krat večje od koncentracij, ugotovljenih v plazmi.
English: This leaflet was last approved in {MM/YYYY}
Slovenian: To navodilo za uporabo je bilo nazadnje potrjeno {MM/LLLL}
English: Ceftriaxone is usually given once a day.
Slovenian: Ceftriakson se običajno daje enkrat dnevno.
English: If you are on dialysis, the doctor will do tests to make sure you are on the right dose.
Slovenian: • Če ste na dializi, bo zdravnik opravil preizkuse, da se bo prepričal, da prejemate ustrezne odmerke.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such, that the utility of the agent in at least some types of infections is questionable.
Slovenian: Po potrebi si je treba prizadevati za pridobitev strokovnega nasveta kadar je pogostnost odpornosti v nekem kraju taka, da je koristnost zdravila pri najmanj nekaj vrstah okužb vprašljiva.
English: If you stop taking Ceftriaxone
Slovenian: Če prenehate uporabljati ceftriakson
English: The contents of the infusion bottles, once opened, should be used immediately.
Slovenian: Vsebino infuzijskih stekleničk, ko so enkrat odprte, je treba uporabiti takoj.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Slovenian: Pogostnost pridobljene odpornosti za izbrane vrste se lahko spreminja glede na zemljepisni položaj in čas, zato so zaželene lokalne informacije o odpornosti, še posebno kadar gre za zdravljenje hudih okužb.
English: The breakpoints for sensitivity are 2 µg/ml for Haemophilus spp.
Slovenian: Prelomne točke za občutljivost so 2 µg/ml za Haemophilus spp.
English: You should check with your doctor or pharmacist if you are not sure.
Slovenian: Pogovorite se s svojim zdravnikom ali farmacevtom, če niste čisto prepričani.
English: The proposed dosage range from 20-50-80 mg/kg/day allows the continuation of long lasting therapeutic experience supported by the recommendations of learned societies.
Slovenian: Predlagani obseg odmerjanja 20-50-80 mg/kg/dan omogoča nadaljevanje dolgotrajnega zdravljenja, ki ga podpirajo priporočila akademskih in strokovnih združenj.
English: There are no data on the use of ceftriaxone in pregnant women.
Slovenian: Na voljo ni nobenih podatkov o uporabi ceftriaksona pri nosečnicah.