FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Memantine Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Memantine Accord in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine Accord should be re-assessed on a regular basis.
Slovenian: Accord je treba oceniti v 3 mesecih od začetka zdravljenja, nato pa je treba redno ocenjevati koristi nadaljnjega zdravljenja s tem zdravilom.
English: What is Memantine Accord and what is it used for?
Slovenian: Kaj je zdravilo Memantine Accord in za kaj se uporablja?
English: For practical information about using Memantine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Memantine Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Accord has been shown to have comparable quality and is considered bioequivalent to Axura.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Memantine Accord primerljivo raven kakovosti kot referenčno zdravilo Axura ter da mu je biološko enakovredno.
English: For more information about treatment with Memantine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju s tem zdravilom preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Memantine Accord
Slovenian: Druge informacije o zdravilu Memantine Accord
English: Memantine Accord is a ‘generic medicine'.
Slovenian: Zdravilo Memantine Accord je „generično zdravilo“.
English: No additional studies in patients were required as Memantine Accord was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Axura.
Slovenian: Dodatne študije pri bolnikih niso bile potrebne, ker je bilo dokazano, da ima zdravilo Memantine Accord primerljivo raven kakovosti kot referenčno zdravilo Axura ter da mu je biološko enakovredno.
English: Memantine Accord is a medicine that contains the active substance memantine.
Slovenian: Memantine Accord je zdravilo, ki vsebuje zdravilno učinkovino memantin.
English: Therefore, the CHMP's view was that, as for Axura, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi tako kot pri zdravilu Axura odtehtajo znana tveganja.
English: The active substance in Memantine Accord, memantine, is an antidementia medicine.
Slovenian: Zdravilna učinkovina v zdravilu Memantine Accord, memantin, je zdravilo za zdravljenje demence.
English: It is not intended to provide practical advice on how to use Memantine Accord.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Memantine Accord approved?
Slovenian: Zakaj je bilo zdravilo Memantine Accord odobreno?
English: How has Memantine Accord been studied?
Slovenian: Kako je bilo zdravilo Memantine Accord raziskano?
English: How is Memantine Accord used?
Slovenian: Kako se zdravilo Memantine Accord uporablja?
English: How does Memantine Accord work?
Slovenian: Kako zdravilo Memantine Accord deluje?
English: Although this difference is not large, it may benefit some patients.
Slovenian: Čeprav ta razlika ni velika, lahko nekaterim bolnikom koristi.
English: There is a risk of severe allergic reactions, and although it is not known exactly how often these reactions occur, they appear to be rare.
Slovenian: Obstaja tveganje za hude alergijske reakcije in čeprav ni znano, kako pogosto se te reakcije pojavljajo, se zdijo redke.
English: It is given once only, within 48 hours after symptoms start.
Slovenian: Zdravilo se da samo enkrat, v 48 urah po začetku simptomov.
English: Further information on Alpivab can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Alpivab so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Medicines Agency decided that Alpivab'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 Alpivab večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The dose depends on age and body weight and should be reduced in adults and adolescents over 13 years of age with reduced kidney function.
Slovenian: Odmerek je odvisen od starosti in telesne mase ter ga je treba zmanjšati pri odraslih in mladostnikih, starejših od 13 let, z zmanjšanim delovanjem ledvic.
English: What measures are being taken to ensure the safe and effective use of Alpivab?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alpivab?
English: Alpivab is given as an infusion lasting 15 to 30 minutes.
Slovenian: Zdravilo Alpivab se daje v obliki infuzije, ki traja od 15 do 30 minut.
English: It is used to treat uncomplicated influenza (flu) in adults and children over 2 years.
Slovenian: Uporablja se zdravljenje nezapletene influence (gripe) pri odraslih in otrocih, starejših od dveh let.
English: As for all medicines, data on the use of Alpivab are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Alpivab stalno spremljajo.
English: Other information about Alpivab
Slovenian: Druge informacije o zdravilu Alpivab
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alpivab 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 Alpivab upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Alpivab are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Alpivab, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Alpivab have been shown in studies?
Slovenian: Kakšne koristi zdravila Alpivab so se pokazale v študijah?
English: What is Alpivab and what is it used for?
Slovenian: Kaj je zdravilo Alpivab in za kaj se uporablja?
English: Why is Alpivab authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Alpivab odobreno v EU?
English: For more information about using Alpivab, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Alpivab glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of Alpivab and why it is authorised in the EU
Slovenian: Pregled zdravila Alpivab in zakaj je odobreno v EU
English: What are the risks associated with Alpivab?
Slovenian: Kakšna tveganja so povezana z zdravilom Alpivab?
English: Alpivab reduces the length of time flu symptoms last by one day on average.
Slovenian: Zdravilo Alpivab skrajša trajanje simptomov gripe povprečno za en dan.
English: Alpivab is an antiviral medicine that contains the active substance peramivir.
Slovenian: Alpivab je protivirusno zdravilo, ki vsebuje učinkovino peramivir.
English: Uncomplicated means that the flu has typical features (such as fever, aches, cough, sore throat and runny nose) and is not made worse by other conditions.
Slovenian: Nezapletena gripa pomeni, da ima ta tipične značilnosti (npr. vročino, bolečine, kašelj, boleče grlo in izcedek iz nosu) in ne poteka težje zaradi drugih bolezni.
English: Peramivir works on neuraminidases of both influenza-A (the most common type) and influenza-B viruses.
Slovenian: Peramivir deluje na nevraminidaze virusov influence A (najpogostejša vrsta) in influence B.
English: Serious side effects with Alpivab are anaphylaxis (a severe allergic reaction) and skin reactions, including erythema multiforme (an allergic skin reaction) and Stevens-Johnson Syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Slovenian: Resni neželeni učinki zdravila Alpivab so anafilaksija (huda alergijska reakcija) in kožne reakcije, vključno z multiformnim eritemom (alergijsko kožno reakcijo) in Stevens-Johnsonovim sindromom (življenjsko nevarno reakcijo z gripi podobnimi simptomi in bolečim izpuščajem, ki se pojavi na koži, v ustih, na očeh in na spolovilu).
English: Alpivab was compared with placebo (a dummy treatment) in one main study of 296 adults with influenza (mostly influenza A) treated within 48 hours of symptoms appearing.
Slovenian: Zdravilo Alpivab so primerjali s placebom (zdravilom brez učinkovine) v eni glavni študiji pri 296 odraslih bolnikih z influenco (večinoma influenco A), zdravljenih v 48 urah po pojavu simptomov.
English: The active substance in Alpivab, peramivir, prevents the flu virus from spreading further by blocking the activity of enzymes (proteins) on the surface of the virus called neuraminidases.
Slovenian: Učinkovina v zdravilu Alpivab, peramivir, preprečuje nadaljnje širjenje virusa tako, da zavira dejavnost encimov (beljakovin) na površini virusa, imenovanih nevraminidaze.
English: The main measure of effectiveness was the length of time before symptoms (cough, sore throat, headache, blocked nose, feverishness or chills, aches or pains of the muscle or joints and tiredness) got better.
Slovenian: Glavno merilo učinkovitosti je bilo trajanje obdobja pred izboljšanjem simptomov (kašlja, bolečega grla, glavobola, zamašenega nosu, vročičnosti ali mrzlice, bolečin v mišicah ali sklepih in utrujenosti).
English: The most common side effects with Alpivab (which may affect up to around 3 in 100 people) are a decrease in the levels of neutrophils (a type of white blood cell) and nausea (feeling sick).
Slovenian: Najpogostejša neželena učinka zdravila Alpivab (ki se lahko pojavita pri več kot 3 od 100 bolnikov) sta zmanjšanje števila nevtrofilcev (vrste belih krvnih celic) in navzea (siljenje na bruhanje).
English: Alpivab was shown to reduce the length of time symptoms lasted in patients with influenza.
Slovenian: Zdravilo Alpivab skrajšuje trajanje simptomov pri bolnikih z influenco.
English: Symptoms took around 2 and a half days (59 hours) to get better in patients taking Alpivab in comparison with just under 3 and a half days (82 hours) in patients taking placebo.
Slovenian: Do izboljšanja simptomov sta pri bolnikih, ki so jemali zdravilo Alpivab, minila približno dva dneva in pol (59 ur), pri bolnikih, ki so jemali placebo, pa skoraj trije dnevi in pol (82 ur).
English: For the full list of side effects and restrictions with Alpivab, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Alpivab glejte navodilo za uporabo.
English: How is Alpivab used?
Slovenian: Kako se zdravilo Alpivab uporablja?
English: How does Alpivab work?
Slovenian: Kako zdravilo Alpivab deluje?
English: Alpivab is available as a solution to be diluted for infusion (drip) into a vein.
Slovenian: Zdravilo Alpivab je na voljo v obliki raztopine, ki se najprej razredči, nato pa se z infundiranjem (kapalno infuzijo) daje v veno.
English: The mutual recognition procedure (UK/V/0356/001/MR) started on 26 November 2009.
Slovenian: Postopek medsebojnega priznavanja (UK/V/0356/001/MR) se je začel 26. novembra 2009.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by a Concerned Member States, France, that the safety and efficacy of the product had not been sufficiently demonstrated.
Slovenian: Združeno kraljestvo je kot referenčna država članica 2. julija 2010 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na Evropsko agencijo za zdravila zaradi zadržkov, ki jih je izpostavila zadevna država članica Francija, in sicer da varnost in učinkovitost zdravila nista bili zadostno dokazani.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combisyn via a mutual recognition procedure in Austria, Belgium, Denmark, Finland, France, Portugal and Spain on the basis of the marketing authorisation granted by the United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom družba Norbrook Laboratories Ltd je predložila vlogo za zdravilo Combisyn prek postopka medsebojnega priznavanja v Avstriji, Belgiji, na Danskem, Finskem, v Franciji, na Portugalskem in v Španiji na podlagi dovoljenja za promet z zdravilom, ki je bilo odobreno v Združenem kraljestvu.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Combisyn Lactating Cow Intramammary Suspension is negative, and therefore adopted an opinion on 6 April 2011 recommending the refusal of the granting of the marketing authorisations and suspension of the existing marketing authorisation.
Slovenian: CVMP je zato po presoji ocene trenutno razpoložljivih podatkov, ki jo je opravil poročevalec, menil, da je razmerje med koristmi in tveganji za zdravilo Combisyn Lactating Cow Intramammary Suspension negativno, in 6. aprila 2011 sprejel mnenje, v katerem priporoča zavrnitev odobritve dovoljenja za promet z zdravilom in začasen umik obstoječega dovoljenja za promet.
English: Combisyn is intended for the treatment of mastitis in lactating cows.
Slovenian: Zdravilo Combisyn je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije.
English: There was disagreement between the Reference Member State and the Concerned Member States on the demonstration of bioequivalence and the adequacy of the proposed withdrawal period.
Slovenian: Referenčna država članica in zadevna država članica se nista strinjali glede dokazov biološke enakovrednosti in ustreznosti predlagane karence.
English: Combisyn Lactating Cow Intramammary Suspension (Combisyn) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Slovenian: Zdravilo Combisyn Lactating Cow Intramammary Suspension (Combisyn) je intramamarna suspenzija, ki vsebuje amoksicilin, klavulansko kislino in prednizolon.
English: These effects are more frequent if you also drink alcohol.
Slovenian: Ti učinki so pogostejši, če pijete tudi alkohol.
English: Wait at least 1 hour until the next meal.
Slovenian: Z naslednjim obrokom počakajte vsaj 1 uro.
English: This medicine should be taken twice a day.
Slovenian: To zdravilo je treba jemati dvakrat na dan.
English: The liquid has a sweet taste.
Slovenian: Tekočina je sladkega okusa.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Slovenian: Približno 2 % radioaktivnosti se je izločilo v urinu.
English: The 3 studies demonstrated similar survival rates.
Slovenian: Te tri študije so pokazale podobne deleže preživetja.
English: Most patients completely recover after appropriate measures are taken.
Slovenian: Večina bolnikov si po vpeljavi ustreznih ukrepov popolnoma opomore.
English: blindness not known:
Slovenian: slepota ni znano:
English: To date, no other relevant epidemiological data are available.
Slovenian: Do sedaj ni na voljo drugih relevantnih epidemioloških podatkov.
English: It is not known exactly how often these side effects occur.
Slovenian: Ni natančno znano, kako pogosto se pojavijo ti neželeni učinki.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Slovenian: Spodaj navedeni priporočeni začetni odmerki se upoštevajo le kot smernice.
English: Schisandra sphenanthera.
Slovenian: Schisandre sphenanthere.
English: It could potentially influence the health of the baby or adversely influence the course of the pregnancy.
Slovenian: To bi lahko vplivalo na zdravje otroka ali negativno vplivalo na potek nosečnosti.
English: Infections including opportunistic infections
Slovenian: Okužbe, vključno z oportunističnimi okužbami
English: Stir, or swirl gently until the granules have been suspended completely.
Slovenian: Mešajte ali nežno vrtinčite, dokler zrnca niso povsem suspendirana.
English: Suspend the granules in water.
Slovenian: Zrnca suspendirajte v vodi.
English: Place the cup with water on a stable surface.
Slovenian: Posodico z vodo postavite na stabilno površino.
English: When treating rejection, these same doses may be used.
Slovenian: Pri zdravljenju zavrnitve se lahko uporabijo enaki odmerki.
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained.
Slovenian: Odmerek je treba prilagajati, da se zagotovi vzdrževanje podobne sistemske izpostavljenosti.
English: During treatment, careful monitoring with EBV-PCR is recommended.
Slovenian: Med zdravljenjem je priporočljivo skrbno nadziranje z EBV-PCR.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 17 Feb 2014
Slovenian: Datum zadnjega podaljšanja: 17 februar 2014
English: Modigraf reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Slovenian: Zdravilo Modigraf omeji obrambni mehanizem vašega telesa (imunski sistem), ki ne bo tako dober pri premagovanju okužb.
English: Modigraf is used in adults and children.
Slovenian: Zdravilo Modigraf se uporablja pri odraslih in otrocih.
English: If you follow these instructions, you will get the right amount of granules from the sachet.
Slovenian: Ob upoštevanju teh navodil boste iz vrečk dobili pravo količino zrnc.
English: No studies on the effects of tacrolimus (Modigraf) on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu takrolimusa (Modigraf) na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: An updated RMP should be submitted
Slovenian: Posodobljen je treba RMP predložiti:
English: In case of sun exposure, wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Slovenian: V primeru izpostavljenosti soncu nosite primerna zaščitna oblačila in uporabljajte sredstva za sončenje z visokim zaščitnim faktorjem.
English: Children and adolescents will receive doses of Modigraf calculated in the same way as adults.
Slovenian: Otroci in mladostniki bodo prejeli odmerke zdravila Modigraf izračunane na enak način kot pri odraslih.
English: Your doctor will tell you exactly how many sachets to take.
Slovenian: Zdravnik vam bo natančno povedal, koliko vrečk morate jemati.
English: If you have forgotten to take your Modigraf, wait until it is time for the next dose, and then continue as before.
Slovenian: Če ste pozabili vzeti zdravilo Modigraf, počakajte do naslednjega odmerka, in nadaljujte kot običajno.
English: Your doctor will advise you on the number of sachets that you need to open and the volume of water that is required to make a suspension.
Slovenian: Vaš zdravnik vam bo povedal, koliko vrečk morate odpreti in koliko vode potrebujete za pripravo suspenzije.
English: Rinse the glass or cup once with the same amount of water and drink this, too.
Slovenian: Z enako količino vode enkrat sperite kozarec ali lonček, ter spijte tudi to vodo.
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Slovenian: V sistemskem obtoku je v nizki koncentraciji prisoten le eden od neaktivnih presnovkov.
English: Data on oral bioavailability of Modigraf in other indications is not available.
Slovenian: Podatki o biološki uporabnosti zdravila Modigraf pri drugih indikacijah niso na voljo.
English: toxic epidermal necrolysis (Lyell's syndrome)
Slovenian: toksična epidermalna nekroliza (Lyellova bolezen)
English: Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Slovenian: Primerjavo v literaturi objavljenih koncentracij ter individualnih vrednosti v klinični praksi je treba previdno oceniti in poznati uporabljene metode.
English: If the physical appearance has changed from the normal white granules, or if dose instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Slovenian: Če se je spremenil fizični videz tega zdravila , ki so normalno bela zrnca, ali so se spremenila navodila za jemanje, se čimprej pogovorite z zdravnikom ali s farmacevtom, da zagotovite, da imate pravo zdravilo.
English: In general children need higher doses per kg of body weight to achieve the same effective levels in the blood as adults.
Slovenian: Na splošno otroci potrebujejo večje odmerke na kg telesne mase za doseganje enake učinkovitosti v krvi kot odrasli.
English: How to prepare the Modigraf sachets for use?
Slovenian: Kako pripraviti vrečke zdravila Modigraf za uporabo?
English: Not known (frequency cannot be estimated from the available data): Abnormality of the optic nerve (optic neuropathy)
Slovenian: Ni znano (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo): - prizadetost vidnega živca (nevropatija vidnega živca)
English: This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Slovenian: Ta pristop je namenjen bolnikom brez okvar organov (npr. okvara ledvic).
English: Elderly patients There is no evidence currently available to indicate that dosing should be adjusted in older people.
Slovenian: Starejši ljudje Trenutno ni dokazov, da bi bila pri starejših ljudeh potrebna prilagoditev odmerjanja.
English: Investigations very common:
Slovenian: Preiskave zelo pogosti:
English: Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Slovenian: Jemanje je treba začeti v roku petih dni po koncu operacije, takoj ko se bolnikovo stanje stabilizira.
English: You will need to take Modigraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Slovenian: Zdravilo Modigraf boste morali jemati vsak dan, dokler potrebujete imunosupresijo za preprečitev zavrnitve presajenega organa.
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po pogostnosti takole: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Modigraf with food and drink
Slovenian: Zdravilo Modigraf skupaj s hrano in pijačo
English: If you need to have any vaccinations, please tell your doctor before.
Slovenian: Če morate opraviti cepljenje s katerimkoli cepivom, to prej povejte zdravniku.
English: Absorption of tacrolimus is variable.
Slovenian: Absorpcija takrolimusa je variabilna.
English: Children and adolescents may experience the same side effects as adults.
Slovenian: Otroci in mladostniki Pri otrocih in mladostnikih se lahko pojavijo enaki neželeni učinki kot pri odraslih.
English: Severe effects may occur, including allergic and anaphylactic reactions (a very serious type of allergic reaction with fainting and difficulty breathing, which needs immediate medical attention).
Slovenian: Pojavijo se lahko resni neželeni učinki, vključno z alergijskimi in anafilaktičnimi reakcijami (zelo hud tip alergijske reakcije z omedlevanjem in težkim dihanjem, ki zahteva takojšnjo zdravniško pomoč).