FrancophonIA/ELRC3.0 huggingface dataset:
English: Ulipristal Acetate Gedeon Richter may cause mild dizziness (see section 4 “Possible side effects”).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ulipristal Acetate Gedeon Richter lahko povzroči blago omotico (glejte poglavje 4 »Možni neželeni učinki«).
English: Ear and labyrinth disorders
Slovenian: vključno z motnjami labirinta vertigo
English: Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.
Slovenian: Zdravilo Ulipristal Acetate Gedeon Richter vsebuje zdravilno učinkovino ulipristalacetat.
English: Ulipristal acetate should only be prescribed after careful diagnosis.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Ulipristalacetat se sme predpisati samo po skrbni diagnozi.
English: Not applicable.
Slovenian: In ga ni mogoče izključiti.
English: 10 mg/day N=132
Slovenian: 10 mg/ dan N=132
English: How to take Ulipristal Acetate Gedeon Richter
Slovenian: Kako jemati zdravilo Ulipristal Acetate Gedeon Richter
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gedeon Richter
English: Adverse reactions during treatment course 1 Very common Common
Slovenian: Neželeni učinki v 1. ciklu zdravljenja
English: It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.
Slovenian: za ustavitev ali zmanjševanje krvavitev in za povečevanje števila eritrocitov.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: DD month YYYY Date of latest renewal: DD month YYYY
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA DD/MM/LLLL
English: If you have been prescribed several courses of Ulipristal Acetate Gedeon Richter 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Slovenian: Acetate Gedeon Richter, lahko začnete vsak cikel šele med drugo menstruacijo po koncu prejšnjega zdravljenja.
English: Administration of the potent CYP3A4 inducer rifampicin (300 mg twice daily for 9 days) to healthy female volunteers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite by 90% or more and decreased ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Slovenian: Uporaba močnega induktorja CYP3A4, rifampicina (300 mg dvakrat dnevno 9 dni), je pri zdravih prostovoljkah znatno zmanjšala Cmax in AUC ulipristalacetata ter njegovega aktivnega presnovka za
English: Do not take Ulipristal Acetate Gedeon Richter if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.
Slovenian: Povejte svojemu zdravniku, če veste, da imate težave z jetri ali če imate kakšne pomisleke glede stanja jeter.
English: 2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Ulipristal Acetate Gedeon Richter treatment)
Slovenian: PREISKAVA (2 - 4 tedne po prenehanju zdravljenja z zdravilom Ulipristal Acetate Gedeon Richter)
English: 10 mg/day N=107
Slovenian: 10 mg/ dan N=107
English: Ulipristal acetate 10 mg/day N=94
Slovenian: Ulipristal acetat 10 mg/dan N=94
English: Other medicines and Ulipristal Acetate Gedeon Richter Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Following administration of the potent CYP3A4 inhibitor ketoconazole (400 mg once daily for 7 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 2 and 5.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 2.4 fold while the Cmax of the active metabolite decreased (0.53 fold change).
Slovenian: zdravim prostovoljkam, se je Cmax ulipristalacetata povečala za 2-krat, AUC pa za 5,9-krat ; AUC aktivnega metabolita ulipristalacetata se je povečala za 2,4-krat, medtem ko se je Cmax aktivnega metabolite zmanjšala (0,53-kratna sprememba).
English: Ulipristal Acetate Gedeon Richter 5 mg tablets Ulipristal acetate
Slovenian: Ulipristal Acetate Gedeon Richter 5 mg tablete ulipristalacetat
English: Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
Slovenian: - bolečine v mišicah in kosteh, - votlinice s tekočino v jajčnikih (ciste na jajčnikih), občutljive dojke/bolečine v dojkah, bolečine v spodnjem delu trebuha (medenici), vročinski oblivi, - utrujenost,
English: NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets
Slovenian: IME ZDRAVILA Ulipristal Acetate Gedeon Richter 5 mg tablete
English: Uterine haemorrhage
Slovenian: otekanje dojk
English: • Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Ulipristal Acetate Gedeon Richter
Slovenian: • Izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo (ginekologi), ki vsebuje: o spremno pismo,
English: Headache*
Slovenian: vročinski oblivi*
English: If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
Slovenian: bolečina v desnem hipohondriju, anoreksija, zlatenica), je treba zdravljenje prekiniti, bolnico pa nemudoma pregledati in opraviti preiskave delovanja jeter.
English: Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
Slovenian: Omejenemu številu preskušancev so dajali enkratne odmerke do 200 mg in dnevne odmerke 50 mg v
English: Patient card
Slovenian: Opozorilna kartica za bolnico
English: SIGNS AND SYMPTOMS OF POSSIBLE LIVER PROBLEMS Stop treatment and contact a doctor right away if you observe any of the following signs or symptoms:
Slovenian: Če opazite katerega od naslednjih znakov ali simptomov, takoj prekinite zdravljenje in o tem obvestite svojega zdravnika: • utrujenost, huda utrujenost
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v mišicah in skeletu bolečine v hrbtu
English: Concomitant use of ulipristal acetate and potent CYP3A4 inducers (e.g. rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efavirenz, nevirapine, long term use of ritonavir) is not recommended (see section 4.5).
Slovenian: karbamazepina, okskarbazepina, fenitoina, fosfenitoina, fenobarbitala, primidona, šentjanževke, efavirenza, nevirapina, dolgotrajna uporaba ritonavirja) ni priporočljiva (glejte poglavje 4.5).
English: Ulipristal acetate 10 mg/day N=95
Slovenian: Ulipristal acetat 10 mg/dan N=95
English: You should avoid drinking grapefruit juice while on treatment with Ulipristal Acetate Gedeon Richter.
Slovenian: Zdravilo Ulipristal Acetate Gedeon Richter skupaj s hrano in pijačo Med jemanjem zdravila Ulipristal Acetate Gedeon Richter se izogibajte uživanju soka grenivke.
English: Mannitol
Slovenian: omotica
English: - Certain medicines used to treat HIV infection (e.g. ritonavir, efavirenz, nevirapine).
Slovenian: karbamazepin, okskarbazepin, primidon), - nekatera zdravila za zdravljenje okužbe z virusom HIV (npr. ritonavir, efavirenz, nevirapin), - zdravila za zdravljenje bakterijskih okužb (npr. rifampicin, telitromicin, klaritromicin,
English: ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETS PATIENT CARD
Slovenian: ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETE OPOZORILNA KARTICA ZA BOLNICO
English: • the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia.
Slovenian: Modulator Associated Endometrial Changes) in kako se ti učinki razlikujejo od učinkov neoviranega estrogena, • diferencialna diagnoza med PAEC, neoviranim estrogenom in hiperplazijo endometrija.
English: • the need to inform the pathologist that patients were treated with Ulipristal Acetate Gedeon Richter if biopsy/surgical samples are to be sent for analysis.
Slovenian: • če se vzorci biopsije/kirurški vzorci pošiljajo na analizo, je treba patologe obvestiti, da so bolnice prejemale zdravilo Ulipristal Acetate Gedeon Richter, ,
English: In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Ulipristal Acetate Gedeon Richter less effective.
Slovenian: Poleg tega lahko hormonska kontracepcijska sredstva in progestageni (npr.
English: What Ulipristal Acetate Gedeon Richter contains - The active substance is ulipristal acetate.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ulipristal Acetate Gedeon Richter - Učinkovina je ulipristalacetat.
English: pain, hot flushes - tiredness (fatigue) - weight increase.
Slovenian: - glavobol, - vrtoglavica (vertigo),
English: Oedema Asthenia
Slovenian: cikel zdravljenja
English: The lining of the uterus may thicken or change as a result of taking Ulipristal Acetate Gedeon Richter.
Slovenian: Jemanje zdravila Ulipristal Acetate Gedeon Richter lahko povzroči odebelitev ali spremembe maternične sluznice.
English: If you take more Ulipristal Acetate Gedeon Richter than you should Experience with Ulipristal Acetate Gedeon Richter when several doses are taken at once is limited.
Slovenian: Izkušnje z jemanjem večjega števila odmerkov zdravila Ulipristal Acetate Gedeon Richter so omejene.
English: Method of administration Oral use.
Slovenian: Peroralna uporaba.
English: Similar results were obtained for the active mono-N-demethylated metabolite.
Slovenian: N-demetiliranem presnovku so dobili približno enake rezultate.
English: Dr. Ondřej Slanař (Czech Republic)
Slovenian: dr. Ondřej Slanař (Češka republika)
English: 27 February 2009, 24 August 2009 ,19 October 2009 and 23 December 2009
Slovenian: 27. februarja 2009, 24. avgusta 2009, 19. oktobra 2009 in 23. decembra 2009
English: The European Commission issued a decision on 10 June 2010.
Slovenian: Evropska komisija je odločbo izdala dne 10. Junija 2010.
English: The final agreed wording describes some possible combinations.
Slovenian: Končno sprejeto besedilo navaja nekatere možne kombinacije.
English: The company that markets these medicines is AstraZeneca.
Slovenian: Družba, ki trži ta zdravila, je AstraZeneca.
English: Dr. Barbara van Zwieten-Boot (the Netherlands)
Slovenian: dr. Barbara van Zwieten-Boot (Nizozemska)
English: In children:
Slovenian: Pri otrocih:
English: 24 July 2008
Slovenian: 24. julij 2008
English: The European Medicines Agency has completed a review of Losec.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Losec.
English: Losec is authorised in the EU via national procedures.
Slovenian: Zdravilo Losec je v EU odobreno z nacionalnimi postopki.
English: Losec is also available in the EU under other trade names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole AstraZeneca and Zoltum.
Slovenian: Zdravilo Losec je v EU na voljo tudi pod drugimi tržnimi imeni: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole AstraZeneca in Zoltum.
English: 4.5 Interactions with other medicinal products
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili
English: • Zollinger-Ellison syndrome.
Slovenian: • Zollinger-Ellisonov sindrom.
English: 20 January 2010
Slovenian: 20. januar 2010
English: Questions and answers on Losec and associated names (omeprazole, 10, 20 or 40 mg capsules and tablets, and 40 mg solution for injection and solution for infusion)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Losec in povezanimi imeni (omeprazol 10, 20 ali 40 mg kapsule in tablete ter 40 mg raztopina za injiciranje in raztopina za infundiranje)
English: The way the medicine is taken has been harmonised, clarifying the starting doses and maintenance doses for all the recommended indications.
Slovenian: Usklajen je bil način uporabe zdravila, ki pojasnjuje začetne in vzdrževalne odmerke za vse priporočene indikacije.
English: The Committee agree that the capsules and tablets can be used for the same indications, namely: In adults:
Slovenian: Odbor je potrdil, da se lahko kapsule in tablete uporabljajo za iste indikacije, in sicer:
English: 10 June 2010
Slovenian: 10. junij 2010
English: The CHMP recommended that this indication be removed as the studies presented by the company did not show an improved effectiveness when compared with placebo (a dummy treatment).
Slovenian: CHMP je priporočil, da se ta indikacija umakne, saj študije, ki jih je predložila družba, ne dokazujejo izboljšanja učinkovitosti v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
English: The Committee noted that there were differences between Member States regarding the use of Losec in H. pylori eradication treatment, especially with regards to the number of antibiotics to combine with Losec (either one or two), and the recommended antibiotics and their doses.
Slovenian: Odbor je ugotovil, da so med državami članicami razlike glede uporabe zdravila Losec pri eradikaciji bakterije H. pylori, zlasti glede števila antibiotikov za kombiniranje z zdravilom Losec (eden ali dva) ter priporočenih antibiotikov in njihovih odmerkov.
English: Losec is used to treat diseases where the stomach produces too much acid.
Slovenian: Zdravilo Losec se uporablja za zdravljenje bolezni, pri katerih želodec proizvaja preveč kisline.
English: The CHMP agreed that the indications for the injectable form of Losec should be the same as for the tablets, but that the injection should only be used when the administration of the tablets or capsules is not possible.
Slovenian: CHMP je potrdil, da morajo biti indikacije za zdravilo Losec v obliki injekcij iste kot pri tabletah, vendar da se injekcija uporablja le, če dajanje tablet ali kapsul ni mogoče.
English: The CHMP acknowledged that the differences existed because of differences in the availability of, and pattern of resistance to, various antibiotics between Member States.
Slovenian: CHMP je potrdil, da je do razlik prišlo zaradi razlik med državami članicami glede razpoložljivosti in vzorca odpornosti na različne antibiotike.
English: The CHMP harmonised the SmPC sections on pregnancy and lactation, the ability to drive and use machines, undesirable effects and overdose.
Slovenian: CHMP je uskladil poglavja povzetka glavnih značilnosti zdravil glede nosečnosti in dojenja, sposobnosti vožnje in upravljanja s stroji, neželenih učinkov in prevelikega odmerjanja.
English: Why was Losec reviewed?
Slovenian: Zakaj je bilo zdravilo Losec pregledano?
English: The CHMP agreed on harmonised indications (the diseases for which the medicine may be used).
Slovenian: CHMP je potrdil usklajene indikacije (bolezni, pri katerih se zdravilo lahko uporablja).
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Slovenian: Deluje tako, da zavira „protonske črpalke“ - beljakovine, ki se nahajajo v specializiranih celicah v želodčni sluznici in črpajo kislino v želodec.
English: The information on how to handle administration in patients who cannot swallow the tablets and capsules has also been harmonised.
Slovenian: Usklajene so bile tudi informacije o uporabi pri bolnikih, ki tablet in kapsul ne morejo pogoltniti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Losec and associated names in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Losec in povezanih imen.
English: This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SmPCs), labelling and package leaflets in the countries where the product is marketed.
Slovenian: To je v različnih državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz razlik med povzetki glavnih značilnosti zdravila, označevanjem in navodili za uporabo v državah, kjer se zdravilo trži.
English: The 10 and 20 mg tablets may be available as non-prescription medicines (over-the-counter, OTC) in some Member States.
Slovenian: 10 in 20 mg tablete so v nekaterih državah članicah na voljo kot zdravilo brez recepta.
English: Losec must not be used in people who are allergic to omeprazole or to any other ingredients in the medicine, and in people being treated with nelfinavir.
Slovenian: Zdravilo Losec se ne sme uporabljati pri osebah, ki so alergične na omeprazol ali katero koli drugo sestavino zdravila, ter pri osebah, ki se zdravijo z nelfinavirjem.
English: The Committee also recommended that, as a precaution, use of Losec in patients receiving clopidogrel should be discouraged.
Slovenian: Odbor je kot previdnostni ukrep priporočil tudi, da se je treba izogibati uporabi zdravila Losec pri bolnikih, ki prejemajo klopidogrel.
English: What is Losec?
Slovenian: Kaj je zdravilo Losec?
English: Losec was also indicated for use before surgery to prevent acid aspiration (acid moving from the gullet into the lungs during anaesthesia, causing pneumonia).
Slovenian: Zdravilo Losec je bilo indicirano tudi za uporabo pred kirurškim posegom za preprečevanje aspiracije kisline (prehod kisline iz požiralnika v pljuča med anestezijo, kar povzroča pljučnico).
English: The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used).
Slovenian: CHMP je sprejel tudi usklajeno besedilo za kontraindikacije (primere, kadar se zdravilo ne sme uporabljati).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v okviru Odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v celotni EU.
English: By blocking the pumps, omeprazole reduces acid production.
Slovenian: Omeprazol z zaviranjem črpalk zmanjša nastajanje kisline.
English: Losec can also be used for the prevention and treatment of the stomach ulcers that are caused by medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Slovenian: Zdravilo Losec se lahko uporablja tudi za preprečevanje in zdravljenje želodčnih razjed, ki jih povzročajo nekatera zdravila za zdravljenje bolečin in vnetij, imenovana neselektivna nesteroidna protivnetna zdravila, kadar bolnik potrebuje neprekinjeno zdravljenje z neselektivnimi nesteroidnimi protivnetnimi zdravili.
English: Together with antibiotics, it can be used to help rid the stomach of a bacterium called Helicobacter pylori (H. pylori), which is known to cause stomach ulcers.
Slovenian: Skupaj z antibiotiki se lahko uporablja za pomoč pri odstranitvi bakterije Helicobacter pylori (H. pylori), ki povzroča razjede na želodcu, iz želodca.
English: When used as an OTC medicine, the CHMP recommended that the indication be the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Slovenian: Za izdajo kot zdravilo brez recepta je CHMP priporočil, da je indikacija zdravljenje simptomov refluksa (npr. zgage, regurgitacije kisline) pri odraslih.
English: • reflux oesophagitis (treatment, including long-term management after healing),
Slovenian: • refluksni ezofagitis (zdravljenje, vključno z dolgoročnim spremljanjem po ozdravitvi),
English: • Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach).
Slovenian: • Zollinger-Ellisonov sindrom (bolezensko stanje, ki ga povzroča prekomerno izločanje kisline v želodcu).
English: • reflux disease, to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth),
Slovenian: • refluksna bolezen - za zdravljenje simptomov, kot sta zgaga in regurgitacija kisline (vračanje kisline v usta),
English: However, if the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended while high doses of PPI should be avoided.
Slovenian: Vendar je v primeru, da je kombinacija atazanavirja in zaviralcev protonske črpalke neizogibna, priporočljivo skrbno klinično spremljanje (npr. virusno breme), poleg tega pa se je treba izogibati visokim odmerkom zaviralcev protonske črpalke.
English: On 27 June 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Losec in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Losec v EU, je dne 27. junija 2008 zadevo napotila na CHMP.
English: • symptomatic gastro-oesophageal reflux disease,
Slovenian: • simptomatska gastroezofagealna refluksna bolezen,
English: • H. pylori eradication in stomach and duodenum ulcer disease in combination with antibiotics,
Slovenian: • eradikacija bakterije H. pylori pri razjedi na želodcu in dvanajstniku v kombinaciji z antibiotiki,
English: The CHMP also included a warning that treatment with Losec and other PPIs may lead to an increase in infections of the gut.
Slovenian: CHMP je dodal tudi opozorilo, da lahko zdravljenje z zdravilom Losec in drugimi zaviralci protonske črpalke okrepi okužbe črevesja.
English: • In combination with antibiotics in the treatment of duodenal ulcer caused by H. pylori.
Slovenian: • v kombinaciji z antibiotiki pri zdravljenju razjede na dvanajstniku, ki jo povzroča H. pylori.
English: The CHMP noted that, due to interactions, the concomitant use of PPIs may affect the efficacy of atazanavir and other HIV medications whose absorption is pH-dependent.
Slovenian: CHMP je ugotovil, da lahko zaradi medsebojnega delovanja sočasna uporaba zaviralcev protonske črpalke vpliva na učinkovitost atazanavirja in drugih zdravil proti virusu HIV, katerih absorpcija je odvisna od vrednosti pH. CHMP je ugotovil tudi, da je bilo prisotno medsebojno delovanje s klopidogrelom, vendar klinične posledice tega niso jasne.
English: • heartburn and acid regurgitation in gastro-oesophageal reflux disease.
Slovenian: • zgaga in regurgitacija kisline pri gastroezofagealni refluksni bolezni,
English: • reflux oesophagitis (inflammation of the gullet, due to acid),
Slovenian: • refluksni ezofagitis (vnetje požiralnika zaradi kisline),
English: • stomach or duodenal ulcer, including preventing the ulcer from coming back (relapse),
Slovenian: • razjeda na želodcu ali dvanajstniku, vključno s preprečevanjem ponovitve razjed,
English: • stomach ulcers (treatment and prevention of relapse),
Slovenian: • razjede na želodcu (zdravljenje in preprečevanje ponovitve),
English: Co-administration of atazanavir with a PPI such as Losec is not recommended.
Slovenian: Sočasna uporaba atazanavirja in zaviralcev protonske črpalke, kot je zdravilo Losec, ni priporočljiva.
English: Losec 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 za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Losec potrebno usklajevanje.
English: • NSAID associated ulcers (treatment and prevention),
Slovenian: • razjede zaradi neselektivnih nesteroidnih protivnetnih zdravil (zdravljenje in preprečevanje),