FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH presented six clinical trials conducted between 1975 and 1986 as well as a more recent review of antibiotics in postpartum infection.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil šest kliničnih preskušanj, izvedenih med letoma 1975 in 1986, ter novejši pregled antibiotikov pri poporodni okužbi.
English: The MAH presented numerous non-clinical studies conducted between 1983 and 2007 assessing the efficacy of amoxicillin in preventing and treating endocarditis in animal models.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil številne predklinične študije, izvedene med letoma 1983 in 2007, ki so ocenjevale učinkovitost amoksicilina pri preprečevanju in zdravljenju endokarditisa na podlagi živalskih modelov.
English: In addition the MAH provided results of several small clinical trials in children and in adults as well as case studies that support the efficacy of amoxicillin for the treatment of bacterial meningitis.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom predložil rezultate več majhnih kliničnih preskušanj pri otrocih in odraslih ter študije primerov, ki podpirajo učinkovitost amoksicilina pri zdravljenju bakterijskega meningitisa.
English: the CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Amoxil and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom Amoxil in povezana imena, za katera so v Prilogi III navedeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I).
English: The first amoxicillin-containing product was authorised in 1972 and Amoxil has been since authorised in the EU through national procedures.
Slovenian: Zdravilo Amoxil je bilo od tega leta v EU odobreno z nacionalnimi postopki.
English: Therefore the CHMP considered this indication no longer appropriate for amoxicillin.
Slovenian: Odbor CHMP je zato menil, da ta indikacija ni več primerna za amoksicilin.
English: However the CHMP considered that due to the seriousness of the condition and in line with the European Society of Cardiology (ESC), American Heart Association (AHA), British Society of Antimicrobial Chemotherapy (BSAC) and British Cardiac Society (BCS) guidelines only the parenteral formulation was useful in treatment of endocarditis and requested that the indication be removed from the oral formulation.
Slovenian: Pri zdravljenju endokarditisa pa je odbor CHMP menil, da je zaradi resnosti tega stanja in v skladu s smernicami European Society of Cardiology (ESC), American Heart Association (AHA), British Society of Antimicrobial Chemotherapy (BSAC) ter British
English: The data submitted shows that amoxicillin can penetrate the meninges well when inflamed, in both children and adults.
Slovenian: Predloženi podatki kažejo, da lahko amoksicilin dobro prehaja v vnete meninge pri otrocih in odraslih.
English: There are few well-designed randomised controlled trials in patients comparing efficacy of different antibiotics.
Slovenian: Pri teh bolnikih obstaja samo nekaj randomiziranih nadzorovanih preskušanj z dobrim načrtom, ki so primerjala različne antibiotike.
English: The harmonisation of the Quality documentation (Module 3) has been also included in this procedure at the request of the marketing authorisation holder (MAH).
Slovenian: Na zahtevo imetnika dovoljenja za promet z zdravilom je bila v ta postopek vključena tudi usklajena dokumentacija o kakovosti (Modul 3).
English: Whereas
Slovenian: in i.m.)
English: The risk of Jarisch-Herxheimer reaction when amoxicillin is used in treatment of Lyme disease was also included in the harmonised PI.
Slovenian: V usklajene informacije o zdravilu so vključili tudi tveganje Jarisch-Herxheimerjeve reakcije, kadar se amoksicilin uporablja za zdravljenje lymske borelioze.
English: The CHMP was therefore of the view that amoxicillin remains a valid therapeutic option in this indication.
Slovenian: Odbor CHMP je zato menil, da amoksicilin ostaja veljavna možnost zdravljenja pri tej indikaciji.
English: Upper respiratory tract infections
Slovenian: Okužbe zgornjih dihal
English: Acute exacerbations of chronic bronchitis (AECB) - all formulations
Slovenian: Akutne eksacerbacije kroničnega bronhitisa (AEKB) - vse formulacije
English: The MAH updated the section in line with the SmPC Guideline which was accepted by CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je to poglavje posodobil skladno s smernico za povzetek glavnih značilnosti zdravila, kar je odbor CHMP odobril.
English: The MAH has submitted small clinical trials conducted as part of the initial clinical development of oral and parenteral amoxicillin, numerous clinical studies conducted since then, mostly by independent research groups and individuals and studies published in the literature in peer-reviewed journals in support of the proposed harmonised PI.
Slovenian: Imetnik dovoljenja za promet z zdravilom je kot podporo predlaganim usklajenim informacijam o zdravilu predložil majhna klinična preskušanja, ki so jih izvedli kot del prvotnega kliničnega razvoja peroralnega in parenteralnega amoksicilina, številne klinične študije, ki so bile od takrat opravljene, predvsem neodvisne raziskovalne skupine in posamezniki, ter študije, objavljene v literaturi v revijah, ki izvajajo medsebojne preglede.
English: A user test and bridging reports or justification for not providing either were provided for the package leaflet of the different formulations and were considered acceptable by CMHP.
Slovenian: Za navodilo za uporabo za različne formulacije so preložili preiskave uporabnikov in premostitvena poročila ali utemeljitev, zakaj teh niso predložili, kar je odbor CHMP sprejel.
English: The MAH presented a number of clinical studies conducted in adults and children between 1986 and 1999 comparing amoxicillin to placebo or other antibiotics as well as recommendations from guideline groups and meta-analysis that support the use of amoxicillin in adults and children with sinusitis.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil številne klinične študije, izvedene pri odraslih in otrocih med letoma 1986 in 1999, ki so primerjale amoksicilin s placebom ali drugimi antibiotiki, ter priporočila iz skupin smernic in metaanalize, ki podpirajo uporabo amoksicilina pri odraslih in otrocih s sinusitisom.
English: Therefore, the CHMP considered this indication adequate.
Slovenian: Odbor CHMP je zato menil, da je ta indikacija ustrezna.
English: The MAH presented clinical studies conducted in adults and children between 1993 and 2008 as well as recommendations from various treatment guideline groups that support the use of amoxicillin in tonsillitis and pharyngitis particularly that due to group A beta-haemolytic streptococcal infections (GABHS).
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil klinične študije, izvedene pri odraslih in otrocih med letoma 1993 in 2008, ter priporočila iz različnih skupin smernic za zdravljenje, ki podpirajo uporabo amoksicilina pri tonzilitisu in faringitisu, predvsem ki sta posledica beta-hemolitičnih streptokoknih okužb iz skupine A (GABHS).
English: The CHMP was of the view that amoxicillin is a suitable treatment option for AOM in both adults and children.
Slovenian: Odbor CHMP je menil, da je amoksicilin primerna možnost zdravljenja akutnega vnetja srednjega ušesa pri odraslih in otrocih.
English: The MAH presented clinical studies in children and adults, including pregnant women, conducted between 1973 and 1993 with oral and parenteral amoxicillin as well as recommendations from various treatment guideline groups that support the use of amoxicillin in these indications.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil klinične študije, izvedene pri otrocih in odraslih, vključno z nosečnicami, opravljene med letoma 1973 in 1993 s peroralnim in parenteralnim amoksicilinom, ter priporočila iz različnih skupin smernic za zdravljenje, ki podpirajo uporabo amoksicilina pri teh indikacijah.
English: The MAH presented seven clinical studies conducted between 1989 and 2001 as well as recommendations from various treatment guideline groups that support the use of amoxicillin in AECB.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil sedem kliničnih študij, izvedenih med letoma 1989 in 2001, ter priporočila iz različnih skupin smernic za zdravljenje, ki podpirajo uporabo amoksicilina pri AEKB.
English: The indication “lower respiratory tract infections” is approved in all countries where Amoxil has a marketing authorisation, however such general indication is no longer acceptable and the CHMP accepted the MAH proposal to replace it by specific terms, as detailed below.
Slovenian: Indikacija „okužbe spodnjih dihal“ je odobrena v vseh državah, kjer ima zdravilo Amoxil dovoljenje za promet z zdravilom, vendar taka splošna indikacija ni več sprejemljiva, zato je odbor CHMP sprejel predlog imetnika dovoljenja za promet z zdravilom za zamenjavo s podrobnejšimi izrazi, kot je razloženo spodaj.
English: The indication “upper respiratory tract infections” is approved in all countries where Amoxil has a marketing authorisation, however such general indication is no longer acceptable and the CHMP accepted the MAH proposal for replacement by specific terms as detailed below.
Slovenian: Indikacija „okužbe zgornjih dihal“ je odobrena v vseh državah, kjer ima zdravilo Amoxil dovoljenje za promet z zdravilom, vendar taka splošna indikacija ni več sprejemljiva, zato je odbor CHMP sprejel predlog imetnika dovoljenja za promet z zdravilom za zamenjavo s podrobnejšimi izrazi, kot je razloženo spodaj.
English: The CHMP considered the efficacy of amoxicillin in tripled therapy for Helicobacter pylori eradication adequately demonstrated in adults and in children, as a first line or as rescue therapy.
Slovenian: Odbor CHMP je menil, da so učinkovitost amoksicilina kot zdravljenje prve izbire ali reševalno zdravljenje pri trojni terapiji za eradikacijo Helicobacter pylori zadostno dokazali pri odraslih in otrocih.
English: In line with the SmPC guideline and QRD template, the MAH has listed the ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, sorted by MedDRA System Organ Class.
Slovenian: Skladno s smernico za povzetek glavnih značilnosti zdravila in predlogo za pregled kakovosti dokumentov (QRD) je imetnik dovoljenja za promet z zdravilom navedel neželene učinke amoksicilina iz kliničnih študij in nadzora v obdobju trženja, ki so navedeni glede na organski sistem MedDRA.
English: The risk of precipitation in bladder catheter for the parenteral formulation was also included.
Slovenian: Pri parenteralni formulaciji je bilo vključeno tudi tveganje nastanka sedimentacije v katetru, vstavljenem v sečni mehur.
English: including as a first choice, for treatment and prophylaxis of endocarditis.
Slovenian: Več nacionalnih smernic podpira uporabo amoksicilina, vključno s prvo izbiro, za zdravljenje in profilakso pri endokarditisu.
English: The MAH submitted results of six randomised controlled trials comparing amoxicillin alone or in combination with probenecid 500 mg TID to other antibiotics and placebo, as well as an observational cohort study conducted in children and adults between 1989 and 2008 with amoxicillin, all in treatment of type I Lyme disease (erythema migrans).
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil rezultate šestih randomiziranih nadzorovanih preskušanj, ki so samostojni amoksicilin ali njegovo kombinacijo s probenecidom 500 mg trikrat na dan primerjala z drugimi antibiotiki in placebom, ter opazovalno kohortno študijo, izvedeno z amoksicilinom pri otrocih in odraslih med letoma 1989 in 2008.
English: The MAH also considered the SmPC Guideline and implemented the current QRD template.
Slovenian: Imetnik dovoljenja za promet z zdravilom je upošteval tudi smernico za povzetek glavnih značilnosti zdravila in uporabil trenutno veljavno predlogo za pregled kakovosti dokumentov (QRD).
English: The MAH presented clinical studies in paediatrics conducted between 1986 and 2005 including comparative trials with macrolides and cephalosporins as well as recommendations from various treatment guideline groups based in the US and in the EU that support the use of amoxicillin in “acute otitis media”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil klinične študije pri pediatrični populaciji, izvedene med letoma 1986 in 2005, ki so vključevale primerjalna preskušanja z makrolidi in cefalosporini, ter priporočila iz različnih skupin smernic za zdravljenje v ZDA in EU, ki podpirajo uporabo amoksicilina proti „akutnemu vnetju srednjega ušesa“.
English: Prosthetic joints infections (PJIs) - all formulations
Slovenian: Zunajbolnišnična pljučnica (ZBP) - vse formulacije
English: The interaction with test results was moved to section 4.4 in line with the SmPC Guideline.
Slovenian: Skladno s smernico za povzetek glavnih značilnosti zdravila so interakcija z izvidi preiskav premaknili v poglavje 4.4.
English: The MAH presented clinical studies in adults and paediatrics conducted between 1992 and 2008, as well as recommendations from various treatment guideline groups that support the use of amoxicillin in CAP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil klinične študije, izvedene pri odraslih in pediatričnih bolnikih med letoma 1992 in 2008, ter priporočila iz različnih skupin smernic za zdravljenje, ki podpirajo uporabo amoksicilina pri ZBP.
English: Typhoid and paratyphoid fever - oral formulations
Slovenian: Trebušni tifus in paratifus - peroralne formulacije
English: However amoxicillin alone or in combination with metronidazole was found effective in the treatment of severe dental infections in several studies conducted between 1990 and 2005.
Slovenian: Vendar so v več študijah, izvedenih med letoma 1990 in 2005, ugotovili, da je samostojni amoksicilin ali njegova kombinacija z metronidazolom učinkovit pri zdravljenju hudih zobnih okužb.
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling,
Slovenian: • odbor se je strinjal z uskladitvijo povzetka glavnih značilnosti zdravila, označevanja, navodila za uporabo in dokumentacije o kakovosti v Modulu 3, ki so jo predlagali imetniki dovoljenja za promet z zdravilom;
English: Genitourinary tract infections
Slovenian: Okužbe prebavil
English: Nearly a quarter of the patients were over 80 years of age.
Slovenian: Približno četrtina bolnic je bila starejših od 80 let.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Osseor on 21 September 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Osseor, veljavno po vsej Evropski uniji, izdala 21. septembra 2004.
English: Patients should also receive calcium or vitamin D supplements if they are not getting enough from their diet.
Slovenian: Bolniki morajo jemati tudi dodatek kalcija ali vitamina D, če ju ne dobivajo dovolj s prehrano.
English: Osseor is intended for long-term use.
Slovenian: Namenjeno je dolgotrajni uporabi.
English: What measures are being taken to ensure the safe and effective use of Osseor?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Osseor?
English: The full EPAR for Osseor 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 Osseor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Osseor
Slovenian: Druge informacije o zdravilu Osseor
English: Osseor should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Slovenian: Zdravilo Osseor je treba vzeti najmanj dve uri po zaužitju hrane, mleka, mlečnih izdelkov ali kalcijevih dodatkov, najbolje pred spanjem.
English: The company will also carry out a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Slovenian: Družba bo izvedla tudi študijo, v kateri bo ocenjevala učinkovitost vzpostavljenih ukrepov za zmanjšanje tveganja za nastanek težav s srcem in obtočili.
English: What benefit has Osseor shown during the studies?
Slovenian: Kakšne koristi je zdravilo Osseor izkazalo med študijami?
English: These materials will also remind doctors of the approved used of the medicine.
Slovenian: Poleg tega bo gradivo zdravnikom služilo kot opomnik o odobrenih načinih uporabe zdravila.
English: The study looked at changes in the bone density after one year of treatment.
Slovenian: V študiji so proučevali spremembe gostote kosti po enoletnem zdravljenju.
English: A risk management plan has been developed to ensure that Osseor is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Osseor je bil pripravljen načrt obvladovanja tveganj.
English: Treatment should only be started by a doctor with experience of treating osteoporosis.
Slovenian: Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem osteoporoze.
English: For more information about treatment with Osseor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Osseor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Osseor.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Osseor.
English: The most common side effects with Osseor (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Slovenian: Najpogostejši neželeni učinki zdravila Osseor (ki lahko prizadenejo več kot 1 osebo od 10) so preobčutljivostne (alergijske) kožne reakcije (izpuščaji, srbenje, urtikarija ali srbeči izpuščaji in otekanje pod kožo, znano kot angioedem) ter bolečine, ki prizadenejo mišice, kosti in sklepe.
English: In order to reduce the risk of heart attack, Osseor must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Slovenian: Za zmanjšanje tveganja za srčni napad zdravila Osseor ne smejo jemati bolniki z visokim krvnim tlakom, ki ni ustrezno nadzorovan, ali bolniki, ki trenutno imajo ali so v preteklosti imeli katerega koli od naslednjih obolenj:
English: The CHMP decided that Osseor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Osseor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: What is the risk associated with Osseor?
Slovenian: Kakšna tveganja so povezana z zdravilom Osseor?
English: The contents of the sachet are added and mixed into a glass of water to form a suspension, which is drunk just after being prepared.
Slovenian: Vsebina vrečke se v kozarcu vode zmeša v suspenzijo, ki jo je treba popiti takoj po pripravi.
English: • ischaemic heart disease (such as angina or a heart attack);
Slovenian: • ishemično obolenje srca (kot je angina pektoris ali srčni napad);
English: Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Osseor in preventing bone breaks.
Slovenian: Gledano v celoti, pa rezultati druge študije niso zadostno dokazali koristi zdravila Osseor pri preprečevanju zlomov kosti.
English: This showed that the risk of broken bones is reduced.
Slovenian: To je dokaz, da se je tveganje za pojav zloma zmanjšalo.
English: Osseor is taken as one sachet once a day.
Slovenian: Zdravilo Osseor se jemlje v odmerku ene vrečke enkrat na dan.
English: Osseor is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Slovenian: Zdravilo Osseor se uporablja za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških, pri katerih obstaja veliko tveganje za zlom kosti in ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
English: It must not be used in people who are temporarily or permanently immobilised, such as people on bed rest or recovering from surgery.
Slovenian: Prav tako ga ne smejo uporabljati osebe, ki se začasno ali trajno ne morejo gibati, kot so npr. osebe z odrejenim mirovanjem v postelji ali bolniki po operaciji.
English: As there has been some data showing an increased risk of heart attack with Osseor, the decision to prescribe Osseor should take into account the patient's individual heart risk.
Slovenian: Ker nekateri podatki kažejo na povečano tveganje za srčni napad v povezavi z zdravilom Osseor, je treba pri predpisovanju zdravila upoštevati posameznikovo tveganje za srčni napad.
English: • peripheral arterial disease (obstruction of the blood flow in the arteries, usually in the legs);
Slovenian: • periferno arterijsko obolenje (motnje pretoka krvi po arterijah, običajno v nogah);
English: Osseor must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Slovenian: Zdravila ne smejo uporabljati bolniki, ki imajo ali so imeli vensko trombembolijo (težave zaradi nastajanja krvnih strdkov v venah, na primer v nogah ali pljučih).
English: The first study included 1,649 women with osteoporosis who had already had a broken bone in the spine and the second included over 5,000 women whose osteoporosis was affecting the hip.
Slovenian: V prvo študijo je bilo vključenih 1 649 žensk z osteoporozo, ki so že imele zlomljeno kost v hrbtenici, v drugo študijo pa prek 5 000 žensk z osteoporozo, ki je prizadela kolke.
English: It is available as 2 g sachets containing granules that are made up into an oral (by mouth) suspension.
Slovenian: Na voljo je v 2-gramskih vrečkah, ki vsebujejo zrnca za pripravo peroralne raztopine (ki se zaužije skozi usta).
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 Osseor.
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: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Osseor, 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 Osseor in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Osseor has been studied in almost 7,000 elderly women in two large studies.
Slovenian: Zdravilo Osseor so proučevali v dveh obsežnih študijah, ki sta vključevali skoraj 7 000 starejših žensk.
English: Osseor is a medicine that contains the active substance strontium ranelate.
Slovenian: Osseor je zdravilo, ki vsebuje zdravilno učinkovino stroncijev ranelat.
English: Exactly how strontium works in osteoporosis is not fully understood, but it is known to stimulate bone formation and reduce bone breakdown.
Slovenian: Delovanje stroncija pri osteoporozi ni v celoti pojasnjeno, je pa znano, da spodbuja tvorjenje kosti in zmanjšuje njihovo razgradnjo.
English: Why has Osseor been approved?
Slovenian: Zakaj je bilo zdravilo Osseor odobreno?