FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP also aligned the contraindication for the use of Diovan during pregnancy or lactation with recent the recommendations of the Pharmacovigilance experts, and therefore recommended that the contraindication in pregnancy be removed and the recommendation for the use during breast feeding be: “Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
Slovenian: CHMP je prav tako uskladil kontraindikacije za uporabo zdravila Diovan med nosečnostjo ali dojenjem z nedavnimi priporočili strokovnjakov za farmakovigilanco in je tako priporočil, da se kontraindikacija za nosečnost odstrani in da se priporočilo o uporabi med dojenjem glasi: „Ker ni podatkov o uporabi valsartana med dojenjem, zdravilo Diovan (Valsartan) ni priporočljivo; zaželeno je alternativno zdravljenje z bolj uveljavljenimi varnostnimi profili med dojenjem, še posebno med dojenjem novorojenca ali nedonošenca“.
English: Diovan works by blocking the effect of angiotensin II.
Slovenian: Zdravilo Diovan deluje z zaviranjem učinka angiotenzina II.
English: Valsartan may be administered with other heart failure therapies.
Slovenian: Valsartan se lahko uporablja z drugimi zdravili za srčno popuščanje.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo uskladiti v celotni EU.
English: Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Slovenian: Zdravilo Diovan spada v razred zdravil, imenovanih antagonisti receptorjev angiotenzina II, ki pomagajo pri nadzorovanju visokega krvnega tlaka.
English: Diovan can be used to treat patients with hypertension (high blood pressure), patients who just have had a heart attack (between 12 hours and 10 days earlier), or patients with heart failure when they show signs that their heart not working fully, such as shortness of breath, and swelling of the feet and legs due to fluid build-up.
Slovenian: Zdravilo Diovan se lahko uporablja za zdravljenje bolnikov s hipertenzijo (visokim krvnim tlakom), bolnikov, ki so pravkar prestali srčni infarkt (pred 12 urami do 10 dnevi), ali bolnikov s srčnim popuščanjem, ko imajo znake, kot so zasoplost ter zatekanje stopal in nog zaradi zastoja tekočine, ki kažejo na to, da jim srce ne deluje v celoti.
English: Looking at the results of studies where triple combination treatment was used (such as a study called VALIANT), the CHMP noted that as there was no increased mortality in patients receiving all three medicines, and therefore there should be no concerns regarding the triple combination.
Slovenian: CHMP je po pregledu rezultatov študij, pri katerih so uporabili trojno kombinacijsko zdravljenje (kot v študiji, imenovani VALIANT), ugotovil, da ne vidi razloga za zadržke glede trojne kombinacije zdravil, saj se umrljivost pri bolnikih, ki so prejemali vsa tri zdravila, ni povečala.
English: In heart failure, Diovan is used when other types of medicines used in heart failure such as Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers, cannot be used.
Slovenian: Pri srčnem popuščanju se zdravilo Diovan uporablja, ko drugih vrst zdravil, uporabljenih pri srčnem popuščanju, kot so zaviralci angiotenzinske konvertaze (ACE) ali zaviralci beta receptorjev, ne moremo uporabiti.
English: The CHMP noted that there was a divergence on whether the use of Diovan should be contraindicated in patients with kidney failure.
Slovenian: CHMP je opazil neskladje glede tega, ali naj bo uporaba zdravila Diovan pri bolnikih z ledvično odpovedjo kontraindicirana.
English: The CHMP also discussed the indications in the treatment of heart failure and after a recent myocardial infarction (MI).
Slovenian: CHMP je prav tako razpravljal o indikacijah pri zdravljenju srčnega popuščanja in posledic nedavnega miokardnega infarkta.
English: • dosage recommendations in patients with renal and hepatic impairment.
Slovenian: • priporočeni odmerki pri bolnikih z okvaro ledvic in jeter.
English: But considering that valsartan given on its own is at least as effective as captopril (an ACE inhibitor) given on its own in the reduction of total mortality after an acute MI, the CHMP endorsed the harmonised indication: Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours - 10 days) myocardial infarction.
Slovenian: CHMP je ob upoštevanju, da je pri zmanjševanju skupne umrljivosti po akutnem miokardnem infarktu valsartan, dajan samostojno, vsaj tako učinkovit kot kaptopril (zaviralec angiotenzinske konvertaze) samostojno, odobril usklajeno indikacijo: Zdravljenje klinično stabilnih bolnikov s simptomatskim srčnim popuščanjem ali asimptomatsko sistolično disfunkcijo levega prekata po nedavnem (pred 12 urami-10 dnevi) miokardnem infarktu.
English: It can be used on its own and in combination with ACE inhibitors.
Slovenian: Uporabljamo ga lahko samega in v kombinaciji z zaviralci angiotenzinske konvertaze.
English: However, because Diovan is eliminated via the biliary route, the CHMP agreed that it should be contraindicated in patients with severe liver diseases and “should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction”.
Slovenian: Vendar pa se je CHMP strinjal, da mora biti zdravilo Diovan, ker se izloča z žolčem, kontraindicirano pri bolnikih s hudim obolenjem jeter in da „se ne sme dajati bolnikom s hudo okvaro jeter, cirozo ali obstrukcijo žolčevoda“.
English: The Committee noted that there has been no study of valsartan in patients with severe kidney failure, but they did not identify any possible safety issue has he primary route of elimination of valsartan is via the digestive (biliary), not renal route The CHMP therefore recommended that the contraindication be removed.
Slovenian: Odbor je ugotovil, da ni nobene študije o valsartanu pri bolnikih s hudo ledvično odpovedjo, vendar pa ni ugotovil nobenih vprašanj glede njegove varnosti, saj je primarna pot izločanja valsartana prek prebavne (žolčne) in ne ledvične poti.
English: On 30 May 2008 the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Diovan in the EU and the EEA.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Diovan v EU in EGP, je dne 30. maja 2008 zadevo napotila na Odbor za zdravila za uporabo v humani medicini (CHMP).
English: The Committee noted that some Member States (MSs) had a limitation of the use of Diovan after MI to patients intolerant to ACE inhibitors.
Slovenian: Odbor je opozoril, da so imele nekatere države članice omejitev uporabe zdravila Diovan po miokardnem infarktu pri bolnikih, ki zaviralcev angiotenzinske konvertaze niso prenašali.
English: The CHMP endorsed following text: No dosage adjustment is required for patients with a creatinine clearance >10ml/min.
Slovenian: Pri bolnikih z očistkom kreatinina > 10 ml/min prilagoditev odmerka ni potrebna.
English: In conclusion, the CHMP endorsed the following text: “The recommended starting dose of Diovan is 40 mg twice daily.
Slovenian: Na koncu je CHMP odobril naslednje besedilo: „Priporočeni začetni odmerek zdravila Diovan je 40 mg dvakrat dnevno Povečanje titracije na 80 mg in 160 mg dvakrat dnevno mora biti izpeljano z vsaj dvotedenskimi razmiki do največjega odmerka, ki ga bolnik še prenese.
English: Company responses provided on: 20 October 2008 Opinion date:
Slovenian: Odgovori družbe, poslani dne:
English: Diovan has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Diovan potrebno usklajevanje.
English: • the use of Diovan with ACE inhibitors and betablockers (triple combination) in chronic heart failure,
Slovenian: • uporaba zdravila Diovan z zaviralci angiotenzinske konvertaze in zaviralci beta receptorjev
English: • patients with liver impairment or cholestasis (problems with the elimination of bile).The Committee agreed that no initial dose adjustment is needed in patients with mild to moderate impairment of liver function.
Slovenian: Odbor se je strinjal, da pri bolnikih z blago do zmerno okvaro jetrne funkcije prilagoditev začetnega odmerka ni potrebna.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Libertek on 28 February 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Libertek, veljavno po vsej Evropski uniji, izdala 28. februarja 2011.
English: Other information about Libertek
Slovenian: Druge informacije o zdravilu Libertek
English: What measures are being taken to ensure the safe and effective use of Libertek?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Libertek?
English: The full EPAR for Libertek can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Libertek je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients may need to take Libertek for several weeks before it starts to have an effect.
Slovenian: Bolniki morajo jemati zdravilo Libertek več tednov, preden se pokaže njegov učinek.
English: What benefit has Libertek shown during the studies?
Slovenian: Kakšne koristi je zdravilo Libertek izkazalo med študijami?
English: A risk management plan has been developed to ensure that Libertek is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Libertek je bil pripravljen načrt obvladovanja tveganj.
English: This is a summary of the European public assessment report (EPAR) for Libertek.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Libertek.
English: Libertek must not be used in patients who have moderate or severe problems with their liver.
Slovenian: Zdravila Libertek ne smejo uporabljati bolniki z zmernimi ali hudimi težavami z jetri.
English: For more information about treatment with Libertek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Libertek preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: After considering all of the available data on the effects of the medicine, the Committee decided that Libertek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je ob upoštevanju vseh razpoložljivih podatkov o učinkih zdravila zaključil, da so koristi zdravila Libertek večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: In addition, the company that makes Libertek will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Slovenian: Poleg tega bo družba, ki izdeluje zdravilo Libertek, zagotovila, da bodo v vseh državah članicah Evropske unije (EU) zdravstveni delavci, ki bodo predpisovali zdravilo, prejeli izobraževalno gradivo o neželenih učinkih zdravila in njegovi uporabi.
English: In addition, the patients who took Libertek had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Slovenian: Poleg tega so imeli bolniki, ki so jemali zdravilo Libertek, v povprečju 1,1 zmernega ali hudega izbruha bolezni v primerjavi z 1,4 izbruha pri bolnikih, ki so jemali placebo.
English: The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Libertek is appropriate for them.
Slovenian: Zagotovila bo tudi kartice za bolnike z informacijami, ki jih morajo sporočiti zdravniku o simptomih in preteklih boleznih, da bo ta lahko presodil, ali je zdravilo Libertek zanje primerno.
English: Because patients taking Libertek may lose weight, they are advised to weigh themselves on a regular basis.
Slovenian: Ker lahko bolniki, ki jemljejo zdravilo Libertek, shujšajo, jim je treba svetovati redno tehtanje.
English: Libertek is a medicine that contains the active substance roflumilast.
Slovenian: Libertek je zdravilo, ki vsebuje zdravilno učinkovino roflumilast.
English: Libertek is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Slovenian: Zdravilo Libertek se ne uporablja samostojno, ampak kot „dodatek“ k zdravljenju z bronhodilatorji (zdravili, ki širijo dihalne poti v pljučih).
English: The most common side effects with Libertek (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Slovenian: Najpogostejši neželeni učinki zdravila Libertek (opaženi pri 1 do 10 bolnikih od 100) so zmanjšana telesna masa, zmanjšan tek, nespečnost (motnje spanca), glavobol, driska, navzeja (slabost) in bolečine v trebuhu.
English: The active substance in Libertek, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Slovenian: Zdravilna učinkovina v zdravilu Libertek, roflumilast, spada v skupino zdravil, ki jih imenujemo „zaviralci fosfodiesteraze tipa 4 (PDE4)“.
English: 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 Libertek.
Slovenian: 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.
English: Why has Libertek been approved?
Slovenian: Zakaj je bilo zdravilo Libertek odobreno?
English: What is the risk associated with Libertek?
Slovenian: Kakšna tveganja so povezana z zdravilom Libertek?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Libertek, 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 in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: After a year, the patients who took Libertek had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Slovenian: Po enem letu so imeli bolniki, ki so jemali zdravilo Libertek, v povprečju 40 ml večjo vrednost FEV1, medtem ko se je pri tistih, ki so prejemali placebo, ta vrednost zmanjšala za 9 ml.
English: The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Libertek in patients with severe COPD.
Slovenian: CHMP je ugotovil, da obstaja potreba po novih načinih zdravljenja kronične obstruktivne pljučne bolezni in da sta glavni študiji pokazali skromno korist zdravila Libertek pri bolnikih s hudo kronično obstruktivno pljučno boleznijo.
English: Libertek has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Slovenian: Zdravilo Libertek so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v kateri je bilo vključenih več kot 3 000 odraslih bolnikov s hudo kronično obstruktivno pljučno boleznijo, ki so imeli najmanj en izbruh bolezni v preteklem letu.
English: The tablets should be swallowed with water at the same time each day.
Slovenian: Priporočeni odmerek zdravila Libertek je ena tableta enkrat na dan. Tablete je treba pogoltniti z vodo vsak dan ob isti uri.
English: Libertek is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Slovenian: Zdravilo Libertek se uporablja za zdravljenje hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih bolnikih, ki imajo kronični bronhitis (dolgotrajno vnetje dihalnih poti) in pri katerih se izbruhi kronične obstruktivne pljučne bolezni pogosto pojavijo.
English: How has Libertek been studied?
Slovenian: Kako je bilo zdravilo Libertek raziskano?
English: For the full list of all side effects reported with Libertek, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Libertek, glejte navodilo za uporabo.
English: Libertek was shown to be more effective than placebo at treating COPD.
Slovenian: Zdravilo Libertek je bilo učinkovitejše od placeba pri zdravljenju bolnikov s kronično obstruktivno pljučno boleznijo.
English: How does Libertek work?
Slovenian: Kako zdravilo Libertek deluje?
English: What is Libertek used for?
Slovenian: Za kaj se zdravilo Libertek uporablja?
English: How is Libertek used?
Slovenian: Kako se zdravilo Libertek uporablja?
English: The doctor may stop treatment with Libertek if the patient loses too much weight.
Slovenian: Če bolnik izgubi preveč telesne mase, se bo zdravnik morda odločil, da prekine zdravljenje z zdravilom Libertek.
English: What is Libertek?
Slovenian: Kaj je zdravilo Libertek?
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 13 March 2013
Slovenian: Datum prve odobritve: 16. julij 2008 Datum zadnjega podaljšanja: 13. marec 2013
English: See section 2, Do not take Janumet.
Slovenian: Glejte poglavje 2, Ne jemljite zdravila Janumet.
English: The safety and efficacy of Janumet in children and adolescents from birth to < 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Janumet pri otrocih in mladostnikih, od rojstva do starosti < 18 let, nista bili dokazani.
English: If you stop taking Janumet, your blood sugar may rise again.
Slovenian: Če prenehate jemati zdravilo Janumet, se vam krvni sladkor lahko ponovno poviša.
English: Janumet is contraindicated in patients with:
Slovenian: Zdravilo Janumet je kontraindicirano pri:
English: If no adequate strength of Janumet is available, individual monocomponents should be used instead of the fixed-dose combination.
Slovenian: Če ni na voljo ustrezne jakosti zdravila Janumet, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
English: Do not take Janumet: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Janumet: - če ste alergični na sitagliptin ali metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: No animal studies have been conducted with Janumet.
Slovenian: Študij na živalih z zdravilom Janumet niso opravili.
English: Other medicines and Janumet
Slovenian: Druga zdravila in zdravilo Janumet
English: The European Medicines Agency has waived the obligation to submit the results of studies with Janumet in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Janumet za vse podskupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What Janumet is and what it is used for
Slovenian: Kaj je zdravilo Janumet in za kaj ga uporabljamo
English: Janumet must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Slovenian: Uporabo zdravila Janumet je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
English: Your doctor may ask you to stop Janumet.
Slovenian: Zdravnik vam bo morda naročil, da prenehate z jemanjem zdravila Janumet.
English: Janumet with alcohol
Slovenian: Zdravilo Janumet skupaj z alkoholom
English: Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Janumet se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 in za zdravljenje diabetične ketoacidoze.
English: During treatment with Janumet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Slovenian: Med zdravljenjem z zdravilom Janumet bo zdravnik vsaj enkrat letno preveril delovanje ledvic, če pa ste starejša oseba in/ali se vam delovanje ledvic slabša, pa še pogosteje.
English: STOP taking Janumet and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: Zdravilo Janumet takoj PRENEHAJTE jemati in se posvetujte z zdravnikom, če opazite katerega koli od naslednjih resnih neželenih učinkov:
English: What you need to know before you take Janumet
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Janumet
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Janumet.
Slovenian: V nadaljevanju so naštete farmakokinetične lastnosti posameznih učinkovin v zdravilu Janumet.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Janumet.
Slovenian: Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Janumet.
English: Janumet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Slovenian: Zdravilo Janumet lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
English: Pharmacokinetic drug interaction studies with Janumet have not been performed; however, such studies have been conducted with the individual active substances, sitagliptin and metformin.
Slovenian: Študije farmakokinetičnih interakcij z zdravilom Janumet niso bile izvedene, vendar pa so take študije opravili s posameznima učinkovinama, sitagliptinom in metforminom.
English: The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Slovenian: Odmerek zdravila Janumet pri antidiabetičnem zdravljenju je treba prilagoditi na podlagi bolnikovega trenutnega režima zdravljenja, učinkovitosti in tolerabilnosti, pri tem pa se ne sme preseči največjega dovoljenega dnevnega odmerka 100 mg sitagliptina.
English: Avoid excessive alcohol intake while taking Janumet since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Slovenian: Med jemanjem zdravila Janumet ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Opozorila in previdnostni ukrepi").
English: Janumet contains two different medicines called sitagliptin and metformin.
Slovenian: Zdravilo Janumet vsebuje dve različni učinkovini, imenovani sitagliptin in metformin.