natgillin/translations-raw huggingface dataset:
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain. 
Deluje tako, da preprečuje ponovni privzem živčnih prenašalcev 5-hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice.
The Committee also consulted a group of experts specialising in the treatment of metabolic diseases. 
Posvetoval se je tudi s skupino strokovnjakov za zdravljenje presnovnih bolezni.
Sibutramine is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI). 
Sibutramin je zaviralec ponovnega privzema serotonina in noradrenalina (SNRI).
• Pharmacist should no longer dispense sibutramine-containing medicines. 
• Farmacevti ne smejo več izdajati zdravil, ki vsebujejo sibutramin.
Sibutramine-containing medicines are used in the management of obesity. 
Zdravila, ki vsebujejo sibutramin, se uporabljajo za obvladovanje debelosti.
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. 
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.
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. 
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.
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on whether the marketing authorisations for products containing sibutramine should be maintained, changed, suspended or withdrawn across the EU. 
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.
• 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. 
• 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.
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. 
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.
The Committee also looked at other studies on the effectiveness of sibutramine for weight loss. 
Odbor je pregledal tudi druge študije o učinkovitost sibutramina pri zmanjšanju telesne mase.
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. 
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.
By blocking their re-uptake, sibutramine increases the amount of these neurotransmitters in the brain. 
Sibutramin z zaviranjem ponovnega privzema živčnih prenašalcev povečuje njihovo količino v možganih.
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. 
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.
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. 
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.
• Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients. 
• Zdravniki morajo prenehati predpisovati zdravila, ki vsebujejo sibutramin, bolnikom z debelostjo ali čezmerno telesno maso.
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. 
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.
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. 
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.
overweight patient outweighed its risks. 
zaključil, da koristi sibutramina pri obvladovanju debelih bolnikov in bolnikov s čezmerno telesno maso odtehtajo z njim povezana tveganja.
It is used in adults for the following: 
Uporablja se pri odraslih bolnikih za:
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). 
To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
The full EPAR for Inhixa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
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.
What measures are being taken to ensure the safe and effective use of Inhixa? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inhixa?
This is a summary of the European public assessment report (EPAR) for Inhixa. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Inhixa.
This helps to stop the formation of new blood clots and control existing ones. 
S tem pomaga pri preprečevanju nastajanja novih krvnih strdkov in nadzoru nad že nastalimi.
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. 
Odmerek in trajanje zdravljenja ter morebitno kombiniranje z drugimi zdravili so odvisni od bolezni, ki jo je treba preprečiti ali zdraviti.
The safety profiles of the two medicines were also considered similar, based on laboratory testing. 
Na podlagi laboratorijskega preskušanja sta bila kot podobna ocenjena tudi varnostna profila obeh zdravil.
Other information about Inhixa 
Druge informacije o zdravilu Inhixa
The company also provided information from published studies showing the benefits of enoxaparin in preventing and treating blood clots. 
Družba je zagotovila tudi informacije iz objavljenih študij, ki so pokazale koristi enoksaparina pri preprečevanju in zdravljenju krvnih strdkov.
• to treat certain types of myocardial infarction (heart attack); 
• zdravljenje nekaterih vrst miokardnega infarkta (srčne kapi);
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. 
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.
When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart. 
Kadar v krvnih žilah nastanejo strdki, lahko zmanjšajo dotok krvi do organov, vključno s srcem.
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. 
Enoksaparin poveča učinek antitrombina III, tj. naravne snovi, ki nadzoruje faktorje strjevanja krvi in pomaga preprečevati strjevanje krvi v telesu.
The Committee recommended that Inhixa be given marketing authorisation. 
Priporočil je, da se za zdravilo Inhixa izda dovoljenje za promet.
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. 
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.
It is not intended to provide practical advice on how to use Inhixa. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
• to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances. 
• preprečevanje nastajanja krvnih strdkov pri toku krvi skozi hemodializno napravo za odstranitev toksičnih snovi.
For more information about treatment with Inhixa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
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.
Inhixa is an anticoagulant medicine (a medicine to prevent blood clots). 
Inhixa je antikoagulacijsko zdravilo (zdravilo za preprečevanje krvnih strdkov).
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. 
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.
What benefits of Inhixa have been shown in studies? 
Kakšne koristi je zdravilo Inhixa izkazalo v študijah?
What is Inhixa and what is it used for? 
Kaj je zdravilo Inhixa in za kaj se uporablja?
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. 
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.
• to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg); 
• zdravljenje bolezni, povezanih s krvnimi strdki, kot je globoka venska tromboza (pri kateri se strdek razvije v globoki veni, običajno v nogi);
Studies have shown that Inhixa has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors. 
Študije so pokazale, da ima zdravilo Inhixa zelo podobno zgradbo in biološko aktivnost kot zdravilo Clexane ter enak učinek na faktorje strjevanja krvi.
What are the risks associated with Inhixa? 
Kakšna tveganja so povezana z zdravilom Inhixa?
Enoxaparin sodium 
Inhixa natrijev enoksaparinat
In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid). 
Pri zdravljenju nestabilne angine pektoris in srčne kapi se zdravilo Inhixa daje v kombinaciji z aspirinom (acetilsalicilno kislino).
Why is Inhixa approved? 
Zakaj je bilo zdravilo Inhixa odobreno?
For practical information about using Inhixa, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Inhixa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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. 
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.
Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity. 
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.
The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'. 
Zdravilna učinkovina v zdravilu Inhixa, enoksaparin, spada v skupino antikoagulacijskih zdravil, imenovanih „nizkomolekularni heparini“.
For the full list of all side effects reported with Inhixa, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Inhixa, glejte navodilo za uporabo.
• to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart); 
• zdravljenje nestabilne angine pektoris (hude vrste bolečine v prsnem košu, ki je posledica oviranega pritoka krvi v srce);
The reference medicine for Inhixa is Clexane. 
Referenčno zdravilo za zdravilo Inhixa je zdravilo Clexane.
Inhixa is available as a solution for injection in pre-filled syringes. 
Zdravilo Inhixa je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
Doses must be adjusted in patients with severely reduced kidney function. 
Pri bolnikih s hudo okvaro delovanja ledvic je treba odmerke prilagoditi.
Inhixa is a ‘biosimilar medicine'. 
Zdravilo Inhixa je „podobno biološko zdravilo“.
How does Inhixa work? 
Kako zdravilo Inhixa deluje?
How is Inhixa used? 
Kako se zdravilo Inhixa uporablja?
It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood. 
Pri zdravljenju določene vrste srčne kapi, imenovane akutni miokardni infarkt z dvigom spojnice ST (STEMI), se najprej da v obliki injekcije v veno.
The active substance in Inhixa is enoxaparin sodium. 
Zdravilna učinkovina v zdravilu Inhixa je natrijev enoksaparinat.
In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people). 
Zelo pogost neželeni učinek (ki se lahko pojavi pri več kot 1 bolniku od 10) so zvišane ravni jetrnih encimov v krvi (znak možnih težav z jetri).
• to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness; 
zlasti pri bolnikih, pri katerih bo opravljen kirurški poseg ali ki jih strdki bolj ogrožajo, ker morajo zaradi bolezni ležati v postelji;
Anaerobes are generally less sensitive. 
Anaerobi so na splošno manj občutljivi.
References (not all submitted are listed) 
Reference (seznam ne vsebuje vseh predloženih referenc)
The treatment should be continued for at least three days after the signs of the infection have disappeared. 
Zdravljenje mora trajati še vsaj tri dni po tem, ko so znaki okužbe izginili.
• children aged below 5 years 
• otroci, mlajši od 5 let,
Adequate hydration must be ensured. 
Zagotoviti je treba ustrezno hidracijo.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. 
Kemično in fizikalno varnost uporabe so dokazali za 24 ur pri 25 °C.
To be used immediately after the bag is opened. 
Uporabite takoj po odprtju vrečke.
It is advisable never to use several medicines at the same time without consulting your doctor first. 
Ni priporočljivo, da sočasno uporabljate več zdravil, ne da bi se o tem najprej posvetovali z zdravnikom.
If a prolonged treatment is necessary, a reassessment of treatment should be done at 2 months at the latest. 
Če je potrebno podaljšanje zdravljenja je ponovna ocena zdravljenja potrebna najpozneje pri 2 mesecih.
This condition is life-threatening and may have a fatal outcome. 
To stanje je življenjsko nevarno in ima lahko smrtni izid;
Furthermore, you should drink a sufficient amount of liquid (about 1.5 - 2 litres daily). 
Poleg tega morate piti zadostno količino tekočine (približno 1,5-2 litra na dan);
I-37063 Isola della Scala (VR), Italy 
I-37063 Isola della Scala (VR), Italija
Very rare: psychotic reactions. 
Zelo redki: psihotične reakcije.
Sequential therapy can also be used. 
Uporabiti je mogoče tudi sekvenčno terapijo.
Mixing with other solutions: see sections 6.2 and 6.6. 
Mešanje z drugimi raztopinami: glejte poglavji 6.2 in 6.6.
Therefore the bleeding time should be monitored. 
zato je treba spremljati čas krvavitve;
During the referral procedure the Applicant/Marketing Authorisation Holder was requested to submit: 
Med napotitvenim postopkom je moral vlagatelj/imetnik dovoljenja za promet predložiti:
In very rare cases these allergic reactions may lead to life-threatening shock. 
V zelo redkih primerih lahko te alergijske reakcije povzročijo življenjsko nevaren šok;
This may lead to a prolongation of the bleeding time. 
To lahko povzroči podaljšanje časa krvavitve.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
Znotraj vsake skupine pogostnosti so neželeni učinki predstavljeni po padajoči resnosti.
• In this case the kidney function must be frequently (twice per week) monitored. 
• V tem primeru je treba pogosto spremljati delovanje ledvic (dvakrat na teden);
The recommended duration of treatment is 10 - 14 days. 
Priporočeno trajanje zdravljenja je 10 - 14 dni.
The patient should be monitored closely and treated symptomatically with supportive measures. 
Bolnika je treba natančno nadzirati in ga simptomatsko zdraviti s podpornimi ukrepi.
Local reaction: 
Lokalna reakcija:
Further intravenous administration is not contraindicated unless the reactions reoccur or worsen. 
Nadaljnja intravenska uporaba ni kontraindicirana, v kolikor se reakcije ne ponovijo ali poslabšajo.
These events were observed predominantly among patients with further risk factors for QTc prolongation. 
Ti dogodki so bili opaženi predvsem med bolniki z nadaljnimi faktorji tveganja za podaljšanje QTc intervala.
This may increase the risk of methotrexate associated toxic reactions. 
To lahko poveča tveganje za pojav toksičnih reakcij povezanih z metotreksatom.
• Mycobacerium tuberculosis test. 
• Test za bakterijo Mycobacerium tuberculosis.
If you suffer from dizziness, do not drive or operate machines, which require your full concentration. 
Če imate omotico, ne vozite ali upravljajte strojev, ki zahtevajo popolno koncentracijo.
Before starting treatment - if you suffer or have suffered from one of the following diseases: 
Pred začetkom zdravljenja - če imate ali ste imeli katero od naslednjih bolezni:
• you are pregnant or wish to become pregnant 
• če ste noseči ali načrtujete nosečnost,
N-1753 Halden Norway 
N-1753 Halden Norveška
During or after treatment - if one of the following conditions occurs: 
Med ali po zdravljenju - če se pojavi katero od naslednjih stanj:
These recommendations are also in line with current treatment guidelines, with clinical practice in most European countries and with the recommendations of previously approved European original and generic ciprofloxacin products. 
Ta priporočila so usklajena s trenutno veljavnimi smernicami za zdravljenje, s klinično prakso v večini evropskih držav in s priporočili za že odobrene evropske originalne in generične izdelke, ki vsebujejo ciprofloksacin.
This medicine may cause these side effects, particularly if you are older or take a medicine of the socalled steroid group, such as hydrocortisone. 
Zdravilo lahko povzroči te neželene učinke, predvsem če ste starejši ali jemljete zdravila iz tako imenovane steroidne skupine, kot je hidrokortizon.
Other studies comparing efficacy of low and higher dose ciprofloxacin showed superiority of the higher dose both in short term (1, 2) and long term efficacy (2). 
Druge raziskave, v katerih so primerjali učinkovitost nižjih in višjih odmerkov ciprofloksacina, so pokazale prednost višjih odmerkov pri kratkoročni učinkovitosti (1, 2) kot tudi dolgoročni učinkovitosti (2).
Monitoring the level of active substance in the blood provides the most reliable basis for dose adjustment. 
Spremljenje koncentracije zdravilne učinkovine v krvi daje najzanesljivejšo osnovo za prilagoditev odmerka.
Your doctor will monitor you for signs of methotrexate overdose. 
Zdravnik vas bo spremljal za znake prevelikega odmerjanja metotreksata.
This may cause epileptic seizures. 
To lahko povzroči epileptične napade;
• local reactions after administration of this medicine. 
• Lokalne reakcije po uporabi tega zdravila.
Due to the increased risk of local reactions, higher intravenous doses in particular should only be administered via a large vein or a central line. 
Zaradi povečanega tveganja za lokalne reakcije, je treba posebej večje intravenske odmerke aplicirati v veliko veno ali centralno linijo.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. 
Prevalenca odpornosti za izbrane vrste se lahko razlikuje zemljepisno in časovno, zato so zaželeni lokalni podatki o odpornosti, zlasti za zdravljenje hudih okužb.
Depression or psychoses lead to self-endangering behaviour in some cases. 
Depresija ali psihoze v nekaterih primerih povzročijo vedenje, ki ogroža bolnika samega.
Other xanthine derivatives 
Drugi ksantinski derivati
An additional factor for consideration is the emergence of increasing ciprofloxacin resistance, particularly in the last 10-15 years. 
Dodatni dejavnik, ki ga je treba upoštevati, je pojav naraščajoče odpornosti na ciprofloksacin, ki je še posebej prisoten v zadnjih 10-15 letih.