natgillin/translations-raw huggingface dataset:
Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence. 
Zdravljenje z zdravilom Sixmo mora potekati pod nadzorom zdravstvenega delavca, ki ima izkušnje z obvladovanjem odvisnosti od opioidov.
Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids. 
Tri študije, v katerih je sodelovalo 627 bolnikov z odvisnostjo od opioidov, so pokazale, da je zdravilo Sixmo učinkovito pri zmanjševanju uživanja opioidov pri bolnikih.
The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant. 
Podjetje, ki trži zdravilo Sixmo, bo pripravilo izobraževalni program za zdravnike, ki naj bi predpisovali to zdravilo, s podrobnimi informacijami o kirurškem postopku za vstavitev in odstranitev implantata.
Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body. 
Zdravilo Sixmo je na voljo kot implantat, ki se vstavi pod kožo in stalno sprošča buprenorfin v telo.
It must also not be used by patients who cannot have an MRI scan and by patients who have had an excessive formation of scar tissue, as this would make locating and removing the implants more difficult. 
Prav tako se ne sme uporabljati pri bolnikih, pri katerih ni mogoče opraviti slikanja z magnetno resonanco, in tistih, ki imajo v anamnezi pretirano brazgotinjenje, saj bi to otežilo iskanje in odstranjevanje implantatov.
The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable. 
Neželeni učinki zdravila Sixmo so tisti, ki se pričakujejo za zdravila z buprenorfinom, neželeni učinki, povezani s samim implantatom, pa so obvladljivi.
Sixmo can only be obtained by ‘special' prescription. 
Predpisovanje in izdaja zdravila Sixmo je le na „poseben“ recept.
The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before. 
V prvi študiji so zdravilo Sixmo primerjali z implantati s placebom (brez učinkovine) pri 163 bolnikih, ki pred tem niso prejemali buprenorfina.
The insertion and removal of the implant must be performed by a doctor who is experienced in minor surgery and has been trained to carry out the insertion and removal procedures. 
Implantate Sixmo sme vstavljati in odstranjevati le zdravnik, ki je pristojen za izvajanje manjših kirurških posegov in je usposobljen za izvajanje postopkov vstavljanja in odstranjevanja.
During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine. 
V šestmesečnem obdobju zdravljenja je bil odstotek urinskih testov, ki so bili negativni na opioide, okoli 31 % pri uporabi zdravila Sixmo, 13 % pri jemanju placeba in 33 % pri uporabi podjezičnega buprenorfina.
During the first 4 months of treatment, the percentage of negative urine tests for opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo. 
V prvih štirih mesecih zdravljenja je bil odstotek urinskih testov, ki so bili negativni na opioide, pri bolnikih, ki so bili zdravljeni z zdravilom Sixmo, okoli 40 % v primerjavi s približno 28 % pri bolnikih, ki so bili zdravljeni s placebom.
The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue). 
V drugi študiji, v katero je bilo vključenih 287 bolnikov, ki predhodno niso prejemali buprenorfina, so zdravilo Sixmo primerjali z implantati s placebom in podjezičnim buprenorfinom.
How does Sixmo work? 
Kako zdravilo Sixmo deluje?
For the full list of side effects of Sixmo, see the package leaflet. 
Za celoten seznam neželenih učinkov zdravila Sixmo glejte navodilo za uporabo.
How is Sixmo used? 
Kako se zdravilo Sixmo uporablja?
The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e. there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine. 
Po šestih mesecih zdravljenja se je na zdravljenje odzvalo približno 96 % bolnikov, ki so prejemali zdravilo Sixmo (tj. ni bilo dokazov o uživanju opioidov v najmanj štirih od šestih mesecev), v primerjavi s približno 88 % pri bolnikih, ki so prejemali podjezični buprenorfin.
NeoRecormon is available in various strengths from 500 to 50,000 international units (IU). 
Zdravilo NeoRecormon je na voljo v različnih jakostih od 500 do 50 000 mednarodnih enot (i.e.).
The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997. 
Evropska komisija je dovoljenje za promet z zdravilom NeoRecormon, veljavno po vsej Evropski uniji, izdala 17. julija 1997.
The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age. 
Večodmerna formulacija zdravila NeoRecormon vsebuje benzilalkohol in se ne sme dajati otrokom, mlajšim od treh let.
It is also available as a pre-filled syringe. 
Na voljo je tudi kot predhodno napolnjena brizga.
The full EPAR for NeoRecormon 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 NeoRecormon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for NeoRecormon. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NeoRecormon.
What measures are being taken to ensure the safe and effective use of NeoRecormon? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NeoRecormon?
It is available as a powder and solvent in a multidose vial, to be made up into a solution for injection. 
Na voljo je kot prašek in vehikel v večodmerni viali za pripravo raztopine za injiciranje.
For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom NeoRecormon preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• to prevent anaemia in premature babies; 
• preprečevanje anemije pri nedonošenčkih;
The CHMP decided that NeoRecormon's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila NeoRecormon večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels). 
Najpogostejši neželeni učinki (opaženi pri 1 do 10 bolnikih od 100) so hipertenzija (visok krvni tlak), glavobol in tromboembolični dogodki (nastajanje krvnih strdkov v krvnih žilah).
The main measures of effectiveness in most of the studies were whether NeoRecormon increased haemoglobin levels or whether it reduced the need for blood transfusions. 
Glavna merila učinkovitosti v večini študij so se nanašala na vprašanje, ali zdravilo NeoRecormon poveča ravni hemoglobina v krvi oziroma ali zmanjšuje potrebo po transfuziji krvi.
A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila NeoRecormon je bil pripravljen načrt obvladovanja tveganj.
The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo). 
Učinkovitost zdravila NeoRecormon pri zdravljenju ali preprečevanju anemije je bila proučevana v številnih študijah, ki so vključevale anemijo pri kronični ledvični odpovedi (1 663 bolnikov, vključno z nekaterimi primerjalnimi študijami v primerjavi s placebom, tj. zdravilom brez zdravilne učinkovine), avtologno transfuzijo krvi (419 bolnikov, primerjava s placebom), anemijo pri nedonošenčkih (177 dojenčkov, primerjava z stanjem brez zdravljenja) in pri bolnikih z rakom (1 204 bolniki z različnimi vrstami raka, primerjava s placebom).
Other information about NeoRecormon 
Druge informacije o zdravilu NeoRecormon
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 NeoRecormon. 
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.
NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure. 
Zdravilo NeoRecormon je bilo pri povečevanju ravni hemoglobina učinkovitejše od placeba pri bolnikih z različnimi vrstami anemije, vključno s tistimi s kronično ledvično odpovedjo.
It contains the active substance epoetin beta. 
Vsebuje zdravilno učinkovino epoetin beta.
NeoRecormon must not be used in patients who have poorly controlled high blood pressure. 
Zdravilo NeoRecormon se ne sme uporabljati pri bolnikih, pri katerih visok krvni tlak ni zadovoljivo nadzorovan.
What benefit has NeoRecormon shown during the studies? 
Kakšne koristi je zdravilo NeoRecormon izkazalo med študijami?
• to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer that does not affect the bone marrow); 
• zdravljenje anemije, ki povzroča simptome pri odraslih, ki prejemajo kemoterapijo za zdravljenje nemieloidnega raka (raka, ki ne prizadene kostnega mozga);
In patients who are to undergo autologous blood transfusion, NeoRecormon must not be used if they have had a heart attack or stroke within the last month, if they have angina pectoris (a severe type of chest pain), or if they are at risk of deep venous thrombosis (DVT, formation of blood clots in the deep veins of the body, usually in the leg). 
Pri bolnikih, ki bodo imeli avtologno transfuzijo krvi, se zdravilo NeoRecormon ne sme uporabljati, če so v zadnjem mesecu imeli srčni infarkt ali možgansko kap, če imajo angino pektoris (hudo vrsto bolečine v prsih) ali pri katerih obstaja tveganje za nastanek globoke venske tromboze (DVT, nastanek krvnega strdka v globokih venah telesa, običajno v nogi).
NeoRecormon is a medicine that stimulates red-blood-cell growth. 
NeoRecormon je zdravilo za spodbujanje rasti rdečih krvnih celic.
It also increased the amount of blood that could be taken from patients before surgery for autologous blood transfusion and reduced the need for transfusion in premature babies and in cancer patients receiving chemotherapy. 
Prav tako je povečalo količino krvi, ki se jo lahko odvzame bolnikom pred kirurškim posegom za avtologno transfuzijo krvi, in zmanjšalo potrebo po transfuziji krvi pri nedonošenčkih in bolnikih z rakom, ki prejemajo kemoterapijo.
The dose, the frequency of injection, and how long it is used for depend on why NeoRecormon is used, and are adjusted according to the patient's response to treatment. 
Odmerek, pogostost injiciranja in trajanje uporabe zdravila NeoRecormon so odvisni od razloga za uporabo tega zdravila in jih je treba prilagoditi odzivu bolnika.
The types of side effects seen with NeoRecormon depend on the cause of the patient's anaemia. 
Vrste neželenih učinkov, opaženih pri zdravilu NeoRecormon, so odvisne od vzroka bolnikove anemije.
Treatment with NeoRecormon should be initiated by a doctor who has experience in the care of patients with the types of anaemia that NeoRecormon is used to treat and prevent. 
Zdravljenje z zdravilom NeoRecormon mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolnikov z vrstami anemije, za zdravljenje in preprečevanje katerih se uporablja zdravilo NeoRecormon.
• to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly); 
• zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome pri bolnikih s kronično odpovedjo ledvic (dolgotrajnim in napredujočim upadanjem sposobnosti pravilnega delovanja ledvic);
In patients receiving chemotherapy or with chronic renal failure, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally. 
Pri bolnikih, ki prejemajo kemoterapijo, ali pri bolnikih s kroničnim ledvičnim popuščanjem lahko anemijo povzroči pomanjkanje eritropoetina ali nezadostna odzivnost telesa na naravno prisotni eritropoetin.
For the full list of all side effects reported with NeoRecormon, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NeoRecormon, glejte navodilo za uporabo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NeoRecormon, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu z njim so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The active substance in NeoRecormon, epoetin beta, is a copy of a human hormone called erythropoietin. 
Zdravilna učinkovina zdravila v zdravilu NeoRecormon, epoetin beta, je kopija človeškega hormona eritropoetina.
Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow. 
Eritropoetin proizvajajo ledvice, spodbuja pa tvorbo rdečih krvnih celic iz kostnega mozga.
What is the risk associated with NeoRecormon? 
Kakšna tveganja so povezana z zdravilom NeoRecormon?
The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production. 
Epoetin beta v zdravilu NeoRecormon v telesu na enak način spodbuja nastajanje rdečih krvnih celic kot naravno prisotni hormon.
NeoRecormon is used in the following situations: 
Zdravilo NeoRecormon se uporablja za:
For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery. 
Pri bolnikih s kronično ledvično odpovedjo se lahko zdravilo NeoRecormon injicira v veno ali v podkožje, ne sme pa se injicirati v podkožje pri nedonošenčkih in bolnikih na kemoterapiji, medtem ko se mora pri bolnikih, ki so pred odvzemom krvi za kirurški poseg, injicirati v veno.
For more details, see the package leaflet. 
Za več informacij glejte navodilo za uporabo.
Why has NeoRecormon been approved? 
Zakaj je bilo zdravilo NeoRecormon odobreno?
• to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood. 
• povečevanje količine krvi, ki se lahko odvzame odraslim bolnikom z zmerno anemijo, ki čakajo na kirurški poseg, za katerega bodo potrebovali zalogo lastne krvi (avtologna transfuzija krvi).
What is NeoRecormon used for? 
Za kaj se zdravilo NeoRecormon uporablja?
How has NeoRecormon been studied? 
Kako je bilo zdravilo NeoRecormon raziskano?
How is NeoRecormon used? 
Kako se zdravilo NeoRecormon uporablja?
What is NeoRecormon? 
Kaj je zdravilo NeoRecormon?
How does NeoRecormon work? 
Kako zdravilo NeoRecormon deluje?
Benefit/risk 
Koristni učinki/tveganje
In Norway most of these activities were implemented already in 1995 without any effect on the way the product was prescribed and used. 
Na Norveškem so večino teh aktivnosti začeli izvajati že leta 1995 brez kakršnegakoli učinka na način predpisovanja in uporabe zdravila.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CARISOPRODOL (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO KARISOPRODOL (glejte Dodatek I)
The Marketing Authorisation Holder decided on the voluntary withdrawal on the basis of the assessment performed by the Norwegian Competent Authority. 
Imetnik dovoljenja za promet se je odločil za prostovoljni umik na osnovi presoje, ki jo je izvedel nacionalni pristojni organ Norveške.
Alternative options are available in the EU for the concerned indications. 
Za omenjene indikacije so v EU na voljo tudi druge možnosti.
• Data demonstrating that the products can be used safely taking into account information on intoxications from poison centres in Europe. 
• podatke, ki kažejo, da se lahko zdravila uporabljajo na varen način, pri čemer je treba upoštevati informacije o zastrupitvah iz centrov za zastrupitve v Evropi;
The three observational studies published in Norway in 2007 gave evidence for the signals of abuse and impairment identified by the spontaneous reporting system in Norway. 
V treh opazovalnih študijah, ki so bile objavljene na Norveškem leta 2007, so dokazali znake zlorabe in prizadetosti, ki so jih v okviru sistemu spontanega poročanja zabeležili na Norveškem.
• Data demonstrating convincing efficacy and safety derived from appropriately designed clinical trials (including an active comparator) and data justifying the proposed dose. 
• podatke, ki kažejo prepričljivo učinkovitost in varnost in ki so bili pridobljeni v primerno načrtovanih preizkušanjih (vključno z aktivnim primerjalnim zdravilom), ter podatke, ki utemeljujejo priporočeni odmerek;
In addition there is information on spontaneous reports as well as reports from poison centers in Europe and in the US that there are problems related to intoxications. 
Poleg tega obstajajo informacije o spontanih poročilih, kot tudi poročila iz centrov za zastrupitve v Evropi in v ZDA, ki navajajo, da obstajajo težave, povezane z zastrupitvami.
In addition there is data from poison information centres confirming these concerns. 
Poleg tega obstajajo podatki iz informacijskih centrov za zastrupitve, ki potrjujejo te zadržke.
All carisoprodol containing medicinal products in the EU are authorised according to national procedures. 
Vsa zdravila, ki vsebujejo karisoprodol, so v EU odobrena v skladu z nacionalnimi postopki.
Several risk minimisation activities (such as restriction of the indication, recommendation of only short term treatment, supply of only small package and change of the prescription category to a more restrictive) have been proposed by the MAHs. 
Imetniki dovoljenj za promet so predlagali več ukrepov za zmanjšanje tveganja (kot so omejitev indikacije, priporočilo za kratkotrajno zdravljenje, oblikovanje manjših pakiranj in sprememba kategorije predpisovanja v bolj restriktivno).
These symptoms are attributable to the low therapeutic index of carisoprodol. 
Te simptome je mogoče pripisati nizkemu terapevtskemu indeksu karisoprodola.
Medicinal products containing carisoprodol have been available in Europe since 1959 and are authorised in a number of EU Member States (see Annex I for the list of carisoprodol containing medicinal products authorised in the EU). 
Zdravila, ki vsebujejo karisoprodol, so v Evropi na voljo od leta 1959 in so odobrena v številnih državah članicah EU (za seznam zdravil, ki vsebujejo karisoprodol in so odobrena v EU, glejte Dodatek I).
• Detailed risk minimisation measures and ways to ensure that the impact of such measures could be adequately evaluated once in place. 
• podrobno opisane ukrepe za zmanjšanje tveganj in načine zagotavljanja vrednotenja takih ukrepov po začetku njihovega izvajanja.
For other indications authorised in some countries it must be concluded that the efficacy is not documented, but it is based on anecdotal reports on clinical effect. 
Za druge indikacije, ki so odobrene v nekaterih državah, velja, da učinkovitost ni dokumentirana, temveč temelji na ustnih poročilih o kliničnih učinkih.
The pharmacokinetic part of the above mentioned study showed that the blood concentration curve of carisoprodol increases and falls rapidly. 
Farmakokinetični del zgoraj omenjene študije je pokazal, da krivulja koncentracije karisoprodola v krvi hitro zraste in hitro pade.
In the recent observational studies the prescribing patterns continued to be distorted. 
V zadnjih opazovalnih študijah so še vedno opažali popačen vzorec predpisovanja.
The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je o tem razpravljal na plenarnem zasedanju septembra 2007, postopek v skladu s členom 107(2) Direktive 2001/83/ES z vsemi spremembami pa se je začel na seji CHMP septembra 2007.
Furthermore the CHMP took note that there are other effective medications with a more favourable safety profile for the treatment of acute low back pain. 
Poleg tega je CHMP ugotovil, da obstajajo druga učinkovita zdravila z bolj primernim varnostnim profilom za zdravljenje akutnih bolečin v spodnjem delu hrbta.
Acute lower back pain is the only indication that has been documented by three randomised, controlled clinical studies using carisoprodol 350mg performed in the 60's and 70's and which do not fulfill current stardard for the Phase III clinical trials. 
Akutne bolečine v spodnjem delu hrbta so edina indikacija, ki so jo dokumentirali v treh randomiziranih, nadzorovanih kliničnih študijah karisoprodola 350 mg, ki pa so bile izvedene že v šestdesetih in sedemdesetih letih in ne izpolnjujejo današnjih kriterijev III. faze kliničnih preizkušanj.
GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS 
PODLAGA ZA UMIK DOVOLJENJ ZA PROMET Z ZDRAVILI
On 20 April 2007, the Norwegian Competent Authority (NoMA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the decision by the Marketing Authorisation Holder Actavis to voluntarily withdraw as of 1 May 2008 the Marketing Authorisations for carisoprodol containing medicinal products in its Member State. 
Dne 20. aprila 2007 je norveški pristojni organ (NoMA) izdal nujno obvestilo, s katerim je v skladu s členom 107 Direktive 2001/83/ES z vsemi spremembami obvestil države članice, agencijo EMEA in Evropsko komisijo o odločitvi imetnika dovoljenj za promet z zdravili, družbe Actavis, da bo s 1. majem 2008 v državi članici prostovoljno umaknila dovoljenja za promet z zdravili, ki vsebujejo karisoprodol.
The lack of recent safety studies comparing carisoprodol to other analgesic products with a better studied safety profile available for the same indication emphasizes the need for further systematic investigation. 
Ker ni novejših študij varnosti, v katerih bi primerjali karisoprodol z drugimi analgetičnimi zdravili, ki imajo bolje raziskan varnostni profil za isto indikacijo, je potrebno nadaljnje sistematično raziskovanje.