natgillin/translations-raw huggingface dataset:
Powder for infusion and powder for injection
Prašek za infundiranje in prašek za injiciranje
There have been no reports of serious outcomes following overdoses with omeprazole, and thus, no specific treatment has been needed or can be recommended.
Poročil o resnih izidih po prevelikem odmerjanju omeprazola ni, zato specifično zdravljenje ni bilo potrebno ali priporočeno.
Since such ulcers are difficult to treat and are associated with more frequent and more serious complications, preventing relapse is a reasonable course of action.
Ker je takšne razjede težko zdraviti in ker so povezane s pogostejšimi in resnejšimi zapleti, je preprečevanje ponovitve utemeljen ukrep.
Increased gastric pH during omeprazole treatment may affect absorption, while other possible interaction mechanisms are via CYP2C19.
Zvišan želodčni pH med zdravljenjem z omeprazolom morda vpliva na absorpcijo, drugi možni mehanizmi interakcije pa so prek CYP2C19.
The CHMP noted that heartburn was not included in the definition of dyspepsia agreed upon by an international committee of clinical investigators (Rome III Committee).
CHMP je ugotovil, da zgaga ni bila vključena v definicijo dispepsije, kakor jo je opredelil mednarodni odbor kliničnih raziskovalcev (Rimski odbor III).
Section 4.5 - Interactions with other medicinal products and other forms of interactions - all formulations
Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij - vse formulacije
Omeprazole has been reported to interact with some antiretroviral drugs.
Poročali so o interakcijah omeprazola z nekaterimi protiretrovirusnimi zdravili.
All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of 20-120 mg daily.
Hudo bolezen z neustreznim odzivom na druga zdravljenja so učinkovito obvladovali pri vseh bolnikih in pri več kot 90 % bolnikov so ohranili odmerke 20-120 mg na dan.
The known safety profile of omeprazole confirms the absence of direct or indirect danger to human health and the cautionary measures restricting the use to 2 weeks treatment are considered acceptable.
Znani varnostni profil omeprazola potrjuje odsotnost neposredne ali posredne nevarnosti za zdravje človeka, zato se previdnostni ukrep omejitve uporabe na dva tedna zdravljenja šteje za sprejemljivega.
Commitments by the MAH were agreed, as listed in the Letter of Undertaking dated 14 December 2009.
Dogovorjene so bile zaveze imetnika dovoljenja za promet z zdravilom, ki so navedene v jamčevalnem pismu z dne 14. decembra 2009.
Although this food interaction is not likely to be of any clinical relevance, it warrants the recommendation that Losec should preferably be taken without food.
Čeprav ta interakcija s hrano verjetno nima kliničnega pomena, je utemeljeno priporočilo, da je bolje, če se zdravilo Losec vzame brez hrane.
i) Patients considered to be at risk of aspiration of gastric contents during general anaesthesia/Acid aspiration prophylaxis
i) Bolniki, ki so v tveganju za aspiracijo želodčne vsebine med splošno anestezijo/profilaksa aspiracije kisline
The MAH submitted a proposal for harmonisation of the Quality module.
Imetnik dovoljenja za promet z zdravilom je predložil predlog uskladitve modula Kakovost.
Such ulcers are also associated with a high frequency of potentially fatal complications.
Takšne razjede so tudi povezane z večjo pogostnostjo možnih zapletov s smrtnim izidom.
Initial GERD treatment is managed by a symptom-based approach; an empiric trial of acid suppression can be used.
Začetno zdravljenje GERB se obravnava s pristopom na osnovi simptomov; lahko se uporabi empiričen poskus supresije kisline.
The CHMP agreed on the following indications in paediatric patients, in line with the outcome of the EU work-sharing assessment of paediatric data:
CHMP se je strinjal z naslednjimi indikacijami za otroke v skladu z izidom izmenjave vrednotenj pediatričnih podatkov v EU:
This section was rewritten in a more reader friendly style by grouping the possible interactions, increasing the visibility of the most severe clinical consequences and indicating the magnitude of the interaction effects.
To poglavje je bilo na novo napisano v bralcu prijaznejšem slogu z razvrstitvijo možnih interakcij v skupine, s povečanjem vidnosti najhujših kliničnih posledic in prikazom pomembnosti učinkov interakcije.
OVER THE COUNTER PRESENTATIONS: LOSEC 10 AND 20 MG TABLETS (OTC)
OBLIKE, NA VOLJO BREZ RECEPTA: LOSEC 10 IN 20 MG TABLETE (OTC)
However, peptic ulcers and erosions are different clinical entities.
Vendar sta peptična razjeda in erozija drugačna klinična pojava.
Concomitant use with posaconazol and erlotinib should be avoided.
Preprečiti je treba sočasno uporabo posakonazola in erlotiniba.
The legal status of Losec as a ”medicinal products not subject to medical prescription” was considered to be in accordance with the EC Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use.
Odbor je menil, da je pravni status zdravila Losec kot „zdravila, ki se izdaja brez recepta“ v skladu z Smernico ES o spremembi razvrstitve za oskrbo z zdravili za uporabo v humani medicini.
This recommendation is based upon overwhelming data showing that the cure of H. pylori infections reduces ulcer recurrence and complications such as bleeding.
To priporočilo temelji na obsežnih podatkih, ki kažejo, da ozdravitev okužb s H. pylori zmanjša ponovitev razjede in zaplete, kot je krvavitev.
However a number of clarifications were requested, mainly with regards to the Manufacture, Control of Drug Product, Container Closure System and Stability sections, for all formulations.
Vendar so bila zahtevana številna pojasnila, zlasti v zvezi s poglavji o izdelavi, kontroli zdravila, sistemu zaporke vsebnika in obstojnosti za vse formulacije.
- the Summary of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- Povzetek glavnih značilnosti zdravil, označevanje in navodilo za uporabo, ki jih predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
Salmonella and Campylobacter are mentioned; however the mention of C. difficile infections was removed, as the available data did not establish a possible causal relationship between C. difficile infection and the use of PPIs.
Omenjena sta Salmonella in Campylobacter, izbrisana pa je bila omemba okužb s C. difficile, saj razpoložljivi podatki ne dokazujejo možne vzročnosti med okužbo s C. difficile in uporabo zaviralcev protonske črpalke.
The MAH proposed 5 separate SPCs: one for the 10mg, 20 mg, and 40 mg capsules; one for the 10 mg, 20 mg, and 40 mg tablets, one for the 40 mg powder for infusion, one for the 40 mg powder for injection and one for the 10mg and 20 mg tablets for OTC use.
Imetnik dovoljenja za promet z zdravilom je predlagal 5 ločenih povzetkov glavnih značilnosti zdravila: enega za kapsule 10 mg, 20 mg in 40 mg; enega za tablete 10 mg, 20 mg in 40 mg, enega za prašek za infundiranje 40 mg, enega za prašek za injiciranje 40 mg in enega za tablete 10 mg in 20 mg brez recepta.
Gastric ulcers in elderly patients may be located more proximally in the stomach than in younger patients.
Razjede želodca se lahko pri starostnikih nahajajo v bolj proksimalnem delu želodca kot pri mlajših bolnikih.
Section 4.6: Pregnancy and lactation - all formulations
Poglavje 4.6: Nosečnost in dojenje - vse formulacije
The cardinal symptoms associated with GERD are heartburn and regurgitation.
Glavna simptoma, povezana z GERB, sta zgaga in regurgitacija.
The data submitted by the MAH did not sufficiently support the claimed indication and although no unexpected or new safety concerns emerged from these studies, the CHMP considered this indication to be unacceptable given the undemonstrated efficacy.
Podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom niso zadostno podprli predlagane indikacije in čeprav v teh študijah ni bilo nepričakovanih ali novih varnostnih zadržkov, je CHMP menil, da je ta indikacija nesprejemljiva zaradi nedokazane učinkovitosti.
For children and adolescents over 4 years of age treated for duodenal ulcers caused by H. pylori, the selection of the appropriate combination therapy should take into consideration the official national, regional and local guidance regarding bacterial resistance, duration of treatment and appropriate use of antibacterial agents.
Pri otrocih, starejših od 4 let, in mladostnikih, ki se zdravijo zaradi razjede dvanajstnika zaradi H. pylori, je treba pri izbiri ustrezne kombinirane terapije upoštevati uradne nacionalne, regionalne in lokalne smernice o odpornosti bakterij, trajanju zdravljenja in ustrezni uporabi protibakterijskih zdravil.
Experience on use of intravenous formulations of Losec in paediatric patients is limited, however no specific safety issues are predicted.
Izkušnje z uporabo intravenskih formulacij zdravila Losec pri otrocih so omejene, vendar se ne napovedujejo specifični varnostni zadržki.
Based on the European guidelines and literature, and due to the lack of conclusive studies relevant to this indication, this indication and the associated posology was removed from the proposed harmonised SPC.
Na osnovi evropskih smernic in literature ter zaradi pomanjkanja študij z jasnimi zaključki, ki bi bile pomembne za to indikacijo, sta bili ta indikacija ter z njo povezano odmerjanje izbrisani iz predlaganega usklajenega povzetka glavnih značilnosti zdravila.
The CHMP considered that according to almost all existing guidance, all patients with erosions or ulcers associated with H. pylori infection should undergo therapy to eradicate the organism.
CHMP je menil, da bi morali v skladu s skoraj vsemi obstoječimi smernicami pri vseh bolnikih z erozijami ali razjedami, ki so povezane z okužbo s H. pylori, opraviti eradikacijo tega organizma.
Regarding special populations, dose adjustment is not needed in patients with impaired renal function, as omeprazole is almost completely metabolized by CYP450, renal impairment does therefore not influence the pharmacokinetics.
V zvezi s posebnimi populacijami bolnikov prilagajanje odmerka ni potrebno pri bolnikih z okvarjenim delovanjem ledvic, saj CYP450 skoraj popolnoma presnovi omeprazol in zato okvarjeno delovanje ledvic ne vpliva na farmakokinetiko.
In most patients healing occurs within two weeks.
Pri večini bolnikov pride do ozdravitve v dveh tednih.
The likelihood of developing reflux symptoms or oesophageal epithelial injury is a function of a quantitative abnormality of the number of reflux events and/or oesophageal acid exposure.
Verjetnost pojava simptomov refluksa ali poškodb ezofagealnega epitela je funkcija kvantitativne nenormalnosti števila refluksnih dogodkov in/ali ezofagealni izpostavitvi kislini.
Whilst definition of what constitutes typical reflux disease may differ, in general terms, GERD is applied to patients with symptoms suggestive of reflux or complications thereof, but not necessarily with oesophageal inflammation.
Čeprav se definicije, kaj predstavlja tipično refluksno bolezen, razlikujejo, na splošno GERB velja za bolnike s simptomi, ki nakazujejo refluks ali njegove zaplete, vendar ne nujno z vnetjem požiralnika.
“Losec gastro-resistant tablets are indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults”
„Losec gastrorezistentne tablete so indicirane za zdravljenje simptomov refluksa (npr. zgage, regurgitacije kisline) pri odraslih.“
The CHMP agreed on specific dosage and treatment duration recommendations for each individual indication for paediatric patients, taking into account the patients age (≥ 1 year of age, ≥ 2 years of age and children and adolescents over 4 years of age) and weight.
CHMP se je strinjal s specifičnimi priporočili o odmerjanju in trajanju zdravljenja za vsako posamezno indikacijo pri otrocih, pri čemer se upošteva starost (starost ≥ 1 leto, starost ≥ 2 leti ter otroci, starejši od 4 let, in mladostniki) in telesna masa bolnika.
Based on the above, the CHMP considers the benefit/risk ratio of Losec to be favourable and the harmonised Product Information documents to be approvable.
CHMP na osnovi navedenega meni, da je razmerje koristi in tveganja za zdravilo Losec ugodno in da je mogoče usklajene dokumente z informacijami o zdravilu odobriti.
Patients are also instructed to consult a doctor if they have had previous gastric ulcer or gastrointestinal surgery, in case of jaundice, hepatic impairment, or liver disease and if they are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Bolnike se tudi pouči, da se posvetujejo z zdravnikom, če so v preteklosti imeli želodčno razjedo ali kirurški poseg na prebavilih, v primeru zlatenice, okvarjenega delovanja jeter ali bolezni jeter in če zdravijo slabo prebavo ali zgago simptomatsko neprekinjeno že 4 tedne ali dlje.
The SPC also provides guidance on dose adjustments and practical advice on the administration of the formulations.
V povzetku glavnih značilnosti zdravila so tudi priporočila o prilagoditvah odmerka ter praktični nasveti o uporabi formulacij.
The CHMP discussed the association of omeprazole with the occurrence of bone fracture/hip fracture in the elderly, especially osteoporosis affected population.
CHMP je razpravljal o povezavi omeprazola s pojavnostjo zloma kosti/zloma kolka pri starostnikih, zlasti v populaciji z osteoporozo.
The CHMP considered that dual therapies are less effective than triple therapies, but that they could be considered in cases where known hypersensitivity precludes use of any triple combination.
CHMP meni, da so dvotirna zdravljenja manj učinkovita kot tritirna zdravljenja, vendar so možna izbira v primerih, ko znana preobčutljivost izključuje uporabo vseh tritirnih kombinacij.
Patients with impaired hepatic function should be advised by a doctor before taking Losec.
Bolniki z okvarjenim delovanjem jeter se morajo pred uporabo zdravila Losec posvetovati z zdravnikom.
h) “Treatment of Zollinger-Ellison syndrome”
h) „Zdravljenje Zollinger-Ellisonovega sindroma“
The use of endoscopy and/or x-ray in case of acid related ulcers is no longer necessary according to current practice and these techniques are therefore omitted.
V skladu s trenutno prakso uporaba endoskopije in/ali rentgenskega slikanja v primerih razjed, povezanih s kislino, ni več potrebna, zato je bila omemba teh tehnik izvzeta.
Appropriate information on the drug product was also provided, and the physical appearance, manufacture, specification, stability, shelf-life, storage were covered.
Predložene so bile tudi ustrezne informacije o zdravilu, ki so obsegale videz, izdelavo, specifikacijo, obstojnost, rok uporabnosti in shranjevanje.
The latest guidelines include symptoms as the most important part for the diagnosis of GERD.
Zadnje smernice kot najpomembnejšo komponento za diagnozo GERB navajajo simptome.
In particular, the indications and their associated posology recommendations were harmonised.
Predvsem so bile usklajene indikacije in z njimi povezana priporočila o odmerjanju.
The CHMP agreed that the available data on administration of the MUPS tablet immediately after a high-fat breakfast shows delayed and decreased absorption of omeprazole.
CHMP se je strinja, da razpoložljivi podatki o uporabi tablet MUPS neposredno po zajtrku z visoko vsebnostjo maščob kažejo zakasnjeno ali zmanjšano absorpcijo omeprazola.
Concomitant use of omeprazole and clopidogrel is therefore discouraged
Sočasna uporaba omeprazola in klopidogrela se zato odsvetuje.
The interaction with tacrolimus and phenytoin were retained and monitoring was recommended but an interaction with methotrexate was considered unwarranted.
Interakcija med takrolimusom in fenitoinom je bila ohranjena s priporočilom spremljanja, interakcija z metotraksatom pa se je štela za neutemeljeno.
The selection of antibiotics should consider the individual patient's drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.
Pri izbiri antibiotikov je treba upoštevati bolnikovo prenašanje zdravila ter nacionalne, regionalne ter lokalne vzorce odpornosti in smernice za zdravljenje.
The CHMP assessed the potential omeprazole-clopidogrel interaction and considered that a warning is warranted, given the potential seriousness of the observed adverse events.
CHMP je ovrednotil možno interakcijo med omeprazolom in klopidogrelom ter menil, da je opozorilo utemeljeno glede na možno resnost opaženih neželenih učinkov.
If symptom control has not been achieved after four weeks treatment with 20 mg daily, further investigation is recommended.
Če v štirih tednih zdravljenja z 20 mg dnevno ne pride do obvladanja simptomov, so potrebne dodatne preiskave.
Identified or suspected adverse drug reactions are listed in this sections.
V tem poglavju so navedene ugotovljene neželene reakcije in sumi nanje.
The recommended initial dose is 60 mg daily.
Priporočeni začetni odmerek je 60 mg na dan.
An additional statement was inserted for the infusion and injection formulations, stating that based on clinical trials, excessive doses have not led to any dose-related adverse reactions.
Vstavljena je bila dodatna izjava za formulaciji za infundiranje in injiciranje, da so v kliničnih preskušanjih ugotovili, da preveliki odmerki ne povzročijo neželenih reakcij, ki bi bile odvisne od odmerka.
This indication is not generally accepted and the use of PPIs in the treatment of chemical pneumonia is not advocated in the various guidance on treatment/prevention of this pneumonia.
Ta indikacija na splošno ni sprejeta in različne smernice o zdravljenju/preprečevanju kemijske pljučnice ne priporočajo uporabe zaviralcev protonske črpalke za zdravljenje te pljučnice.
There are currently 4 separate formulations of Losec on the market: gastro-resistant tablets, capsules, powder for solution for infusion and powder for solution for injection.
Trenutno so v prometu štiri različne formulacije zdravila Losec: gastrorezistentne tablete, kapsule, prašek za raztopino za infundiranje in prašek za raztopino za injiciranje.
For most indications, a 40 mg daily dose is recommended, although in patients with Zollinger-Ellison Syndrome the recommended initial dose is 60 mg daily.
Za večino indikacij se priporoča 40 mg odmerek, vendar je pri bolnikih z Zollinger-Ellisonovim sindromom priporočeni začetni odmerek 60 mg na dan.
The CHMP noted that study data showed that 20 mg once daily produces a more pronounced and consistent inhibition than the lower doses and therefore agreed on a maximum daily dose of 20 mg. Selftreatment should be limited to a maximum period of 14 days, and the patient should be instructed to consult a doctor if symptoms persist.
CHMP je ugotovil, da podatki študije kažejo, da odmerek 20 mg enkrat na dan povzroči izrazitejše in doslednejše zaviranje kot manjši odmerki, zato se je strinjal, da je največji dnevni odmerek 20 mg. Samozdravljenje je treba omejiti na največ 14 dni in bolnika je treba poučiti, da se posvetuje z zdravnikom, če simptomi ne izzvenijo.
The indication for the treatment of Zollinger Ellison syndrome is already harmonised throughout the EU and the CHMP considered this indication to be approvable.
Indikacija za zdravljenje Zollinger-Ellisonovega sindroma je že usklajena v EU, zato je CHMP menil, da je to indikacijo možno odobriti.
The SPC states that for the tablet and capsule formulations the clinical trial safety experience shows that the adverse event profile in children up to 16 years of age is generally the same as for adults in short- as well as in long-term treatment and that there is no long-term data on the effects on puberty and growth.
V povzetku glavnih značilnosti zdravila je navedeno, da so za tablete in kapsule v kliničnem preskušanju varnosti ugotovili, da je profil neželenih učinkov pri otrocih do 16 leta starosti na splošno enak kot pri odraslih na kratkotrajnem in dolgotrajnem zdravljenju ter da ni dolgoročnih podatkov o učinkih na puberteto in rast.
g) Acid-related dyspepsia
g) Dispepsija, povezana s kislino
The CHMP was of the opinion that prolonged acid inhibition by PPIs may promote vitamin B12 malabsorption and inserted a warning stating that omeprazole may reduce the absorption of vitamin B12 and that this should be considered in patients on long-term therapy.
CHMP je tudi menil, da lahko podaljšano zaviranje kisline z zaviralci protonske črpalke spodbudi malabsorpcijo vitamina B12, in vstavil opozorilo, da lahko omeprazol zmanjša absorpcijo vitamina B12 in da je treba to upoštevati pri bolnikih z dolgotrajnim zdravljenjem.
In most patients healing occurs within four weeks.
Pri večini bolnikov do ozdravitve pride v štirih tednih.
Proximal gastric ulcers are often large, tend to heal slowly, and may be more prone to recur.
Proksimalne razjede želodca so pogosto večje, se počasneje zdravijo in so bolj nagnjene k ponovitvam.
With this proposal, prescription only tablets and capsules will have the same indications for all strengths (bioequivalence between the tablets and the capsules of same strength has been demonstrated), as will the solutions for infusion and injection.
S tem predlogom bi tablete in kapsule na recept imele enake indikacije za vse jakosti (biološka enakovrednost med tabletami in kapsulami enake jakosti je bila dokazana) kot tudi raztopini za infundiranje in injiciranje.
Regarding the eradication of H. pylori in peptic ulcer disease, a number of triple-regimen therapies (Losec plus two antibiotics) are proposed.
V zvezi z eradikacijo H. pylori pri bolnikih s peptičnimi razjedami so bila predlagana številna tritirna zdravljenja (zdravilo Losec in dva antibiotika).
Regarding the interaction with clopidogrel, in line with the prescription-only recommendation, patients should specifically tell their doctor or pharmacist if they are taking clopidogrel.
V zvezi z interakcijo s klopidogrelom in v skladu s priporočili za oblike, ki se izdajajo na recept, morajo bolniki zdravnika ali farmacevta obvestiti, da jemljejo klopidogrel.
After consultation of the Cardiovascular subgroup of the Efficacy Working Party, the CHMP confirmed that a PK and PD interaction between CYP2C19 inhibitors and clopidogrel is observed, although the clinical implication of this finding is not clear.
Po posvetovanju s kardiovaskularno podskupino pri delovni skupini za učinkovitost je CHMP potrdil, da je ugotovljena farmakokinetična in farmakodinamična interakcija med zaviralci CYP2C19 in klopidogrelom, čeprav klinična posledica tega odkritja ni jasna.
After discussing the various existing texts in the national SPCs and noting that experience on use of intravenous formulations of Losec in paediatric patients is limited, the CHMP adopted the following harmonised indications in adults for Losec for intravenous use, as an alternative to oral therapy:
Po razpravi o različnih obstoječih besedilih v nacionalnih povzetkih glavnih značilnosti zdravila in ugotovitvi, da je izkušenj z uporabo intravenskih formulacij zdravila Losec pri otrocih malo, je CHMP kot alternativo peroralnemu zdravljenju sprejel naslednje usklajene indikacije za intravensko uporabo zdravila Losec pri odraslih bolnikih:
It is administered as a prodrug and specifically and dose-proportionally inhibits the gastric H+/K+-ATPase (proton pump) and thereby inhibits H+ ion transfer into the gastric lumen, which is responsible for acid secretion in the parietal cells of the stomach.
Omeprazol specifično in v odvisnosti od odmerka zavira želodčno H+/K+ATPazo (protonsko črpalko) in s tem zavira prenos H+ ionov v želodčno svetlino, ki je odgovorna za izločanje kisline v parietalnih celicah želodca.
Relief of symptoms after the start of treatment with PPIs may take time, therefore a statement informing patients that 2-3 days might be needed before symptom improvement is perceived was also added.
Do olajšanja simptomov lahko pride šele po določenem času po začetku jemanja zaviralcev protonske črpalke, zato je bila dodana izjava, ki bolnike pouči, da je za izboljšanje simptomov lahko potrebno 2-3 dni.