FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Presented as a volatile spray, this veterinary medicinal product does not require any massage.
Slovenian: Ker je zdravilo v obliki lahko hlapljivega pršila ga pred uporabo ni potrebno pretresati.
English: Hydrocortisone aceponate administered topically accumulates and is metabolised in skin, as suggested by radioactivity distribution studies and pharmacokinetic data.
Slovenian: Na podlagi študije o distribuciji radioaktivnosti in iz farmakokinetičnih podatkovlahko sklepamo, da se po nanašanju na kožo hidrokortizon aceponat v koži akumulira in presnavlja ter ga zaradi tega v krvni obtok pride le minimalna količina.
English: Specific pharmacovigilance requirements:
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 6 August 2010
Slovenian: 6. avgust 2010
English: In total, about 9,800 patients have been followed up for six years.
Slovenian: Skupno so v šestih letih spremljali približno 9 800 bolnikov.
English: The European Commission issued a decision on 6 August 2010.
Slovenian: Evropska komisija je odločbo izdala dne 6. avgusta 2010.
English: Outcome of a procedure under Article 107 of Directive 2001/83/EC
Slovenian: Izid postopka v skladu s členom 107 Direktive 2001/83/ES
English: Sibutramine-containing medicines have been authorised in the European Union (EU) since 1999.
Slovenian: Zdravila, ki vsebujejo sibutramin, so odobrena v Evropski uniji (EU) od leta 1999.
English: On the basis of these data, the German medicines regulatory agency (BfArM) triggered in November 2009 a review under Article 107 of Directive 2001/83/EC.
Slovenian: Na podlagi teh podatkov je nemška regulatorna agencija za zdravila (BfArM) novembra 2009 sprožila pregled v skladu s členom 107 Direktive 2001/83/ES.
English: 1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa and Zelium.
Slovenian: 1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa in Zelium.
English: The CHMP reviewed the responses from the company to a list of questions on the SCOUT study.
Slovenian: CHMP je pregledal odgovore družbe na seznam vprašanj v zvezi s študijo SCOUT.
English: Questions and answers on the suspension of medicines containing sibutramine
Slovenian: Vprašanja in odgovori v zvezi z začasnim umikom zdravil, ki vsebujejo sibutramin
English: The Committee also asked the company to provide six-monthly updates on the progress of the study.
Slovenian: Odbor je družbo tudi pozval, da naj predloži šestmesečne posodobljene podatke o napredku študije.
English: What are the recommendations for prescribers and patients?
Slovenian: Kakšna so priporočila za zdravnike, ki predpisujejo zdravila, in bolnike?
English: What is sibutramine?
Slovenian: Kaj je sibutramin?
English: Patients who wish to stop treatment before seeing their doctor can do so at any time.
Slovenian: Bolniki, ki želijo prenehati zdravljenje, preden obiščejo svojega zdravnika, imajo možnost, da to kadar koli storijo.
English: They should also review the treatment of patients currently treated with the medicine.
Slovenian: Prav tako morajo pregledati potek zdravljenja bolnikov, ki trenutno prejemajo to zdravilo.
English: The European Medicines Agency has completed a review of the safety and effectiveness of sibutramine.
Slovenian: Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti sibutramina.
English: Why was sibutramine reviewed?
Slovenian: Zakaj je bil sibutramin pregledan?
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Živčni prenašalci so kemijske snovi, ki živčnim celicam omogočajo medsebojno sporazumevanje.
English: The increased levels of neurotransmitters in the brain help patients to feel full after a meal, and this helps to reduce their food intake.
Slovenian: Povečane ravni živčnih prenašalcev v možganih pomagajo bolnikom k občutku sitosti po obroku, to pa pomaga zmanjšati njihov vnos hrane.
English: They are available as capsules containing 10 mg or 15 mg sibutramine, under the trade names Reductil and other names1, and as generic medicines.
Slovenian: Na voljo so v obliki kapsul, ki vsebujejo 10 mg ali 15 mg sibutramina, pod trgovskimi imeni Reductil in drugimi imeni1 ter kot generična zdravila.
English: The Committee also noted that it is not clear if this effect on weight loss can be maintained when sibutramine treatment is stopped.
Slovenian: Odbor je ugotovil tudi, da ni jasno, ali je ta učinek na izgubo telesne mase mogoče ohraniti po prenehanju zdravljenja s sibutraminom.
English: Sibutramine was originally reviewed by the Agency in 1999 and 2002, following concerns over its safety, especially cardiovascular side effects (increased blood pressure and heart rate).
Slovenian: Sibutramin je agencija prvič pregledala leta 1999 in 2002 zaradi zadržkov glede njegove varnosti, zlasti glede kardiovaskularnih neželenih učinkov (povečan krvni tlak in srčni utrip).
English: They are used, alongside diet and exercise, in patients who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m², and in patients who are overweight (with a BMI greater than or equal to 27 kg/m²) and also have other obesity-related risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in the blood).
Slovenian: Uporabljajo se poleg diete in telesne vadbe pri bolnikih z debelostjo (zelo povečano telesno maso), pri katerih je indeks telesne mase (ITM) večji ali enak 30 kg/m², ter pri bolnikih s povečano telesno maso (njihov ITM je večji ali enak 27 kg/m²), ki imajo druge z debelostjo povezane dejavnike tveganja, kot sta sladkorna bolezen tipa 2 ali dislipidemija (nenormalne ravni maščobe v krvi).
English: The suspension will remain in place until the company can provide data that are sufficient to allow the identification of a group of patients for whom sibutramine's benefits clearly outweigh its risks.
Slovenian: Začasen umik bo veljal, dokler družba ne bo predložila ustreznih podatkov za identifikacijo skupine bolnikov, pri kateri koristi sibutramina jasno odtehtajo z njim povezana tveganja.
English: Although the full data from the SCOUT study have not yet been analysed, the study's Data Safety Monitoring Board (a body of independent experts appointed to review regularly the outcome of the clinical trial) informed the Agency in October 2009 of preliminary data indicating that sibutramine is associated with more cardiovascular problems than placebo.
Slovenian: Čeprav vsi podatki iz študije SCOUT še niso bili analizirani, je Odbor za spremljanje podatkov o varnosti (organ neodvisnih strokovnjakov, imenovanih za izvajanje rednih pregledov izida kliničnega preskušanja), ki je spremljal študijo, agencijo oktobra 2009 obvestil o predhodnih podatkih, ki kažejo, da sibutramin povzroča več kardiovaskularnih težav kot placebo.
English: Most of the patients in the SCOUT study would not normally be given sibutramine, as the medicine is contra-indicated in patients with cardiovascular disease.
Slovenian: Večina bolnikov v študiji SCOUT navadno ne bi prejelo sibutramina, saj je zdravilo kontraindicirano pri bolnikih s kardiovaskularno boleznijo.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain.
Slovenian: Deluje tako, da preprečuje ponovni privzem živčnih prenašalcev 5-hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice.
English: The Committee also consulted a group of experts specialising in the treatment of metabolic diseases.
Slovenian: Posvetoval se je tudi s skupino strokovnjakov za zdravljenje presnovnih bolezni.
English: Sibutramine is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI).
Slovenian: Sibutramin je zaviralec ponovnega privzema serotonina in noradrenalina (SNRI).
English: • Pharmacist should no longer dispense sibutramine-containing medicines.
Slovenian: • Farmacevti ne smejo več izdajati zdravil, ki vsebujejo sibutramin.
English: Sibutramine-containing medicines are used in the management of obesity.
Slovenian: Zdravila, ki vsebujejo sibutramin, se uporabljajo za obvladovanje debelosti.
English: The CHMP noted that the SCOUT study showed an increased risk of serious cardiovascular events (such as heart attack or stroke) in patients with known cardiovascular disease taking sibutramine.
Slovenian: CHMP je ugotovil, da je študija SCOUT pokazala povečano tveganje za resne kardiovaskularne dogodke (kot sta srčni napad ali infarkt) pri bolnikih z znano kardiovaskularno boleznijo, ki jemljejo sibutramin.
English: Finally, looking at all of the studies of sibutramine in the management of obesity, the CHMP noted that the weight loss achieved with sibutramine treatment is modest in comparison with that obtained with placebo, with patients losing on average two to four kilograms more than with placebo.
Slovenian: Ne nazadnje je CHMP ob upoštevanju vseh študij sibutramina pri obvladovanju debelosti ugotovil, da je zmanjšanje telesne mase po zaslugi zdravljenja s sibutraminom v primerjavi s placebom skromno, saj so bolniki v povprečju izgubili dva do štiri kilograme več kot pri zdravljenju s placebom.
English: They requested that the CHMP assess the impact of the new data on the benefit-risk balance of sibutramine to prepare an opinion on whether the marketing authorisations for products containing sibutramine should be maintained, changed, suspended or withdrawn across the EU.
Slovenian: Odbor CHMP je pozvala, naj oceni vpliv novih podatkov na razmerje med koristmi in tveganji za sibutramin in pripravi mnenje o tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo sibutramin, ohranijo, spremenijo, začasno umaknejo ali odvzamejo v EU.
English: • Patients who are taking a medicine containing sibutramine to help them to lose weight should make an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight.
Slovenian: • Bolniki, ki jemljejo zdravilo, ki vsebuje sibutramin, za pomoč pri izgubi telesne mase, morajo ob prvi priložnosti iti na pregled k svojemu zdravniku, da se pogovorijo o drugih možnostih za izgubo telesne mase.
English: However, the Committee also asked the company that makes Reductil, Abbott Laboratories, to start a study of sibutramine in patients with cardiovascular risk factors, looking particularly at the medicine's safety.
Slovenian: Vendar pa je Odbor tudi pozval družbo Abbott Laboratories, ki izdeluje zdravilo Reductil, da naj izvede študijo sibutramina pri bolnikih s kardiovaskularnimi dejavniki tveganja, zlasti z vidika varnosti zdravila.
English: The Committee also looked at other studies on the effectiveness of sibutramine for weight loss.
Slovenian: Odbor je pregledal tudi druge študije o učinkovitost sibutramina pri zmanjšanju telesne mase.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of sibutramine-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisations for sibutramine-containing medicines be suspended across the EU.
Slovenian: Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo sibutramin, ne odtehtajo z njim povezanih tveganj, zato je priporočil začasen umik dovoljenj za promet z zdravili, ki vsebujejo sibutramin, v celotni EU.
English: By blocking their re-uptake, sibutramine increases the amount of these neurotransmitters in the brain.
Slovenian: Sibutramin z zaviranjem ponovnega privzema živčnih prenašalcev povečuje njihovo količino v možganih.
English: The study compared sibutramine with placebo (a dummy treatment), and looked not only at how much weight the patients were losing, but also at the occurrence of cardiovascular events, such as heart attack, stroke and cardiac arrest.
Slovenian: V študiji so sibutramin primerjali s placebom (zdravilom brez zdravilne učinkovine) in beležili ne le zmanjšanje telesne mase pri bolnikih, temveč tudi pogostost kardiovaskularnih dogodkov, kot so srčni napad, infarkt in zastoj srca.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of sibutramine do not outweigh its risks, and that all marketing authorisations for medicines containing sibutramine should be suspended throughout Europe.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi sibutramina ne odtehtajo z njim povezanih tveganj in da je treba v Evropi začasno umakniti vsa dovoljenja za promet z zdravili, ki vsebujejo sibutramin.
English: • Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients.
Slovenian: • Zdravniki morajo prenehati predpisovati zdravila, ki vsebujejo sibutramin, bolnikom z debelostjo ali čezmerno telesno maso.
English: As a result, in 2002, the company started the SCOUT study (Sibutramine Cardiovascular Outcome Trial) to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese patients at high risk for cardiovascular disease.
Slovenian: V skladu s tem je družba leta 2002 začela študijo SCOUT (preskušanje kardiovaskularnega izida sibutramina), da bi ugotovila učinek izgube telesne mase po zaslugi sibutramina na kardiovaskularne težave pri veliki skupini bolnikov s čezmerno telesno maso ali debelih bolnikov, pri katerih je prisotno visoko tveganje za kardiovaskularne bolezni.
English: Nevertheless the Committed considered that an increased risk can also apply to patients for whom sibutramine can be prescribed because obese and overweight patients are likely to be at risk of cardiovascular disease.
Slovenian: Kljub temu je Odbor menil, da so povečanemu tveganju lahko izpostavljeni tudi bolniki, ki jim je sibutramin mogoče predpisati, saj so bolniki z debelostjo ali čezmerno telesno maso pogosto izpostavljeni tveganju za kardiovaskularne bolezni.
English: overweight patient outweighed its risks.
Slovenian: zaključil, da koristi sibutramina pri obvladovanju debelih bolnikov in bolnikov s čezmerno telesno maso odtehtajo z njim povezana tveganja.
English: It is used in adults for the following:
Slovenian: Uporablja se pri odraslih bolnikih za:
English: This means that Inhixa is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: The full EPAR for Inhixa 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 Inhixa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Inhixa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inhixa?
English: This is a summary of the European public assessment report (EPAR) for Inhixa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Inhixa.
English: This helps to stop the formation of new blood clots and control existing ones.
Slovenian: S tem pomaga pri preprečevanju nastajanja novih krvnih strdkov in nadzoru nad že nastalimi.
English: The dose and how long the medicine is given for, as well as whether it is given with other medicines, depend on the condition to be prevented or treated.
Slovenian: Odmerek in trajanje zdravljenja ter morebitno kombiniranje z drugimi zdravili so odvisni od bolezni, ki jo je treba preprečiti ali zdraviti.
English: The safety profiles of the two medicines were also considered similar, based on laboratory testing.
Slovenian: Na podlagi laboratorijskega preskušanja sta bila kot podobna ocenjena tudi varnostna profila obeh zdravil.
English: Other information about Inhixa
Slovenian: Druge informacije o zdravilu Inhixa
English: The company also provided information from published studies showing the benefits of enoxaparin in preventing and treating blood clots.
Slovenian: Družba je zagotovila tudi informacije iz objavljenih študij, ki so pokazale koristi enoksaparina pri preprečevanju in zdravljenju krvnih strdkov.
English: • to treat certain types of myocardial infarction (heart attack);
Slovenian: • zdravljenje nekaterih vrst miokardnega infarkta (srčne kapi);
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da med zdraviloma Inhixa in Clexane ni klinično pomembnih razlik v učinkovitosti ali varnosti, in menil, da enako kot pri zdravilu Clexane koristi odtehtajo znana tveganja.
English: When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart.
Slovenian: Kadar v krvnih žilah nastanejo strdki, lahko zmanjšajo dotok krvi do organov, vključno s srcem.
English: Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood's clotting factors and helps prevent blood from clotting inside the body.
Slovenian: Enoksaparin poveča učinek antitrombina III, tj. naravne snovi, ki nadzoruje faktorje strjevanja krvi in pomaga preprečevati strjevanje krvi v telesu.
English: The Committee recommended that Inhixa be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Inhixa izda dovoljenje za promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inhixa have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Inhixa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: It is not intended to provide practical advice on how to use Inhixa.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.
Slovenian: • preprečevanje nastajanja krvnih strdkov pri toku krvi skozi hemodializno napravo za odstranitev toksičnih snovi.
English: For more information about treatment with Inhixa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Inhixa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Inhixa is an anticoagulant medicine (a medicine to prevent blood clots).
Slovenian: Inhixa je antikoagulacijsko zdravilo (zdravilo za preprečevanje krvnih strdkov).
English: Inhixa must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke.
Slovenian: Zdravilo Inhixa se ne sme uporabljati pri bolnikih z večjimi krvavitvami, hudimi motnjami strjevanja krvi ali boleznimi, pri katerih se lahko poveča tveganje za krvavitve ali zaradi njih, kot so želodčne razjede ali kap.
English: What benefits of Inhixa have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Inhixa izkazalo v študijah?
English: What is Inhixa and what is it used for?
Slovenian: Kaj je zdravilo Inhixa in za kaj se uporablja?
English: The most common side effect with Inhixa (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Inhixa to prevent blood clots during surgery.
Slovenian: Najpogostejši neželeni učinek zdravila Inhixa (ki se lahko pojavi pri več kot 1 bolniku od 10) je krvavitev; resna krvavitev se je pojavila pri približno štirih bolnikih od 100, ki so zdravilo Inhixa prejeli za preprečevanje krvnih strdkov med kirurškim posegom.
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);
Slovenian: • zdravljenje bolezni, povezanih s krvnimi strdki, kot je globoka venska tromboza (pri kateri se strdek razvije v globoki veni, običajno v nogi);
English: Studies have shown that Inhixa has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors.
Slovenian: Študije so pokazale, da ima zdravilo Inhixa zelo podobno zgradbo in biološko aktivnost kot zdravilo Clexane ter enak učinek na faktorje strjevanja krvi.
English: What are the risks associated with Inhixa?
Slovenian: Kakšna tveganja so povezana z zdravilom Inhixa?
English: Enoxaparin sodium
Slovenian: Inhixa natrijev enoksaparinat
English: In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid).
Slovenian: Pri zdravljenju nestabilne angine pektoris in srčne kapi se zdravilo Inhixa daje v kombinaciji z aspirinom (acetilsalicilno kislino).
English: Why is Inhixa approved?
Slovenian: Zakaj je bilo zdravilo Inhixa odobreno?
English: For practical information about using Inhixa, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Inhixa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In addition, a study in 20 healthy subjects has shown the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
Slovenian: Poleg tega je študija pri 20 zdravih osebah z različnimi merili, ki kažejo na način delovanja zdravila v telesu, pokazala, da enaki odmerki obeh zdravil, dani z injiciranjem pod kožo, povzročijo podobne učinke na faktorje strjevanja krvi.
English: Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity.
Slovenian: Obsežne laboratorijske študije, v katerih so zdravilo Inhixa primerjali z zdravilom Clexane, so pokazale, da je zdravilo Inhixa po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Clexane.
English: The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Slovenian: Zdravilna učinkovina v zdravilu Inhixa, enoksaparin, spada v skupino antikoagulacijskih zdravil, imenovanih „nizkomolekularni heparini“.
English: For the full list of all side effects reported with Inhixa, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Inhixa, glejte navodilo za uporabo.
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Slovenian: • zdravljenje nestabilne angine pektoris (hude vrste bolečine v prsnem košu, ki je posledica oviranega pritoka krvi v srce);
English: The reference medicine for Inhixa is Clexane.
Slovenian: Referenčno zdravilo za zdravilo Inhixa je zdravilo Clexane.
English: Inhixa is available as a solution for injection in pre-filled syringes.
Slovenian: Zdravilo Inhixa je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
English: Doses must be adjusted in patients with severely reduced kidney function.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic je treba odmerke prilagoditi.