natgillin/translations-raw huggingface dataset:
Use of the product deviating from the instructions given in the SPC increases the risk of nephrotoxicity, and may increase the prevalence of bacteria resistant to gentamicin. 
Uporaba zdravila na način, ki odstopa od navodil v povzetku glavnih značilnosti zdravila, poveča tveganje za nefrotoksičnost in lahko poveča razširjenost bakterij, odpornih proti gentamicinu.
The CVMP considered that the lack of data and limited scientific evidence would only support a narrow indication, i.e. “For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.” 
Odbor CVMP je menil, da pomanjkljivi podatki in omejeni znanstveni dokazi podpirajo samo ozko indikacijo, in sicer: „Za zdravljenje okužb spodnjih dihal pri konjih, ki jih povzročajo aerobne gramnegativne bakterije, občutljive za gentamicin.“
Particular caution should be taken when administering gentamicin with other potential nephrotoxic medicinal products (containing e.g. NSAIDs, furosemide, and other aminoglycosides). 
Posebna previdnost je potrebna, kadar se gentamicin daje sočasno z drugimi zdravili, ki so lahko nefrotoksična (zdravili, ki vsebujejo na primer nesteroidne protivnetne učinkovine, furosemid in druge aminoglikozide).
4.7 Use during pregnancy, lactation or lay The safety in pregnant horses is unknown. 
Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila za breje kobile ni znana.
Gentamicin does not penetrate intracellularly, or into abscesses. 
Gentamicin ne prehaja v celice ali abscese.
Foals, calves, sucklings - the first month of life 
Gentamicin žrebeta, teleta, sesni mladičiprvi mesec življenja
This is primarily due to its fast bacteriocidal effect against Gram-negative bacteria, its chemical stability and synergy with beta-lactam antibiotics. 
Razlogi za to so predvsem njegovo hitro baktericidno delovanje proti gramnegativnim bakterijam, njegova kemijska stabilnost in sinergija z betalaktamskimi antibiotiki.
Vijenac A. Cesarca 16 
Vijenac A. Cesarca 16 31000 Osijek Hrvaška
The CVMP notes that there is no MRL for gentamicin for horses. 
Odbor CVMP je upošteval, da za gentamicin za konje ni določena mejna vrednost ostankov.
Two other mechanisms of resistance include ribosomal mutations of the binding site of aminoglycosides, the 30S subunit, and the bacteria decreasing the permeability of aminoglycosides. 
Med preostalimi mehanizmi odpornosti so še ribosomske mutacije vezavnega mesta za aminoglikozide in podenoto 30S ter mehanizem, preko katerega bakterije zmanjšajo prepustnost za aminoglikozide.
The Committee therefore concluded that a single dose of 6.6 mg gentamicin/kg bw given intravenously once daily for 3-5 consecutive days would provide an efficacious dose for adult horses, when used according to the SPC. 
Odbor je zato zaključil, da bo enkratni odmerek 6,6 mg gentamicina/kg telesne mase, dan intravensko enkrat na dan 3-5 zaporednih dni, zagotovil učinkovit odmerek za odrasle konje, če se bo uporabljal v skladu z navodili v povzetku glavnih značilnosti zdravila.
In one mechanism, gentamicin can interfere with the correct amino acid polymerisation and elongation. 
Za prvi mehanizem je značilno, da gentamicin ovira pravilno polimerizacijo in elongacijo aminokislin.
The target animal safety of injectable gentamicin products for horses is considered not proven for use in foals. 
Varnost zdravil za injiciranje, ki vsebujejo gentamicin, za ciljno živalsko vrsto konje ni bila dokazana pri uporabi pri žrebetih.
Gentamicin is primarily distributed within extracellular fluids. 
Gentamicin se v glavnem porazdeli v zunajcelični tekočini.
No margin of safety has been established under the approved dosing regimen. 
Terapevtski indeks pri odobrenem režimu odmerjanja ni bil določen.
The safety in pregnant horses is unknown. 
Varnost zdravila za breje kobile ni znana.
The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to harmonise the indication(s) and dosing regimens of the concerned products, taking into account the available data and in particular with regard to target animal safety. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) so zaprosili, naj ob upoštevanju razpoložljivih podatkov, zlasti tistih, povezanih z varnostjo ciljne živalske vrste, uskladi indikacijo (indikacije) in režime odmerjanja za zadevna zdravila.
Calves, foals and piglets at the age of one month 
Gentamicin teleta, žrebeta in prašički, stari en mesec
31303 Burgdorf Germany 
31303 Burgdorf Nemčija
Therefore, the use of the products in foals is not recommended. 
Uporaba zdravil pri žrebetih se zato ne priporoča.
The Committee considered that for any other indications for horses for injectable products contaning gentamicin, applicants/marketing authorisation holders (MAHs) would need to submit appropriate data, following up-to-date requirements. 
Odbor je menil, da bi predlagatelji/imetniki dovoljenj za promet z zdravilom za katere koli druge indikacije za zdravila za injiciranje, ki vsebujejo gentamicin, pri konjih morali predložiti ustrezne podatke, skladne z najnovejšimi zahtevami.
• on the basis of the available data, the CVMP considered that the dosage regimen should be amended as described in Annex III; 
• odbor CVMP je na podlagi razpoložljivih podatkov menil, da je režim odmerjanja treba spremeniti,
Gentamicin sulphate exerts concentration-dependent bacterial killing characteristics. 
Gentamicinijev sulfat uničuje bakterije v odvisnosti od koncentracije.
Another mechanism predominates at low concentrations in which amino acid codons are misread by tRNA and proof-reading is impaired. 
Drugi mehanizem prevlada pri nizkih koncentracijah, pri katerih tRNA napačno prebere kodone aminokislin, kontrolno branje pa je ovirano.
Germany CP-Pharma Handelsgesellschaft mbH Ostlandring 13 
Nemčija CP-Pharma Handelsgesellschaft mbH Ostlandring 13 31303 Burgdorf Nemčija
Gentamicin is a narrow-spectrum Gram-negative bactericidal antimicrobial, without effects on anaerobe bacteria and mycoplasmas. 
Gentamicin je antibiotik ozkega spektra z baktericidnim delovanjem proti gramnegativnim bakterijam, ki nima učinkov na anaerobne bakterije in mikoplazme.
Only one proprietary study in support of the approved dosing regimen for a product included in the scope of this referral was provided.The CVMP considered this study was of limited value to their assessment. 
Predložena je bila samo ena lastniška študija v podporo odobrenemu režimu odmerjanja za zdravilo, vključeno v sklop tega postopka.
For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin. 
Za zdravljenje okužb spodnjih dihal pri konjih, ki jih povzročajo aerobne gramnegativne bakterije, občutljive za gentamicin.
WITHDRAWAL PERIOD Not authorised for use in horses producing meat or milk for human consumption. 
Ni dovoljena uporaba pri konjih v laktaciji, katerih meso ali mleko je namenjeno prehrani ljudi.
Gentamicin is deactivated in the presence of inflammatory debris, low oxygen environments and low pH. Gentamicin is eliminated unchanged by the kidney via glomerular filtration, including 85-95% of the dose. 
V nespremenjeni obliki se izloča skozi ledvice z glomerulno filtracijo, pri čemer se izloči od 85-95 % odmerka.
Bovine (calves up to 250 kg), porcine (suckling pigs), equine not intended for human consumption, dogs and cats 
govedo (teleta do 250 kg), prašiči (sesni prašiči), konji, ki niso namenjeni za prehrano ljudi, psi in mačke
were justified; 
Prilogi III, utemeljena;
31303 Burgdorf, 
31303 Burgdorf, Nemčija
Enzymatic modification is the most common type of aminoglycoside resistance. 
Najpogostejša vrsta odpornosti proti aminoglikozidom je encimska modifikacija.
Nephrotoxicity is especially a concern in foals. 
Zlasti je zaskrbljujoča nefrotoksičnost pri žrebetih.
O-Phosphotransferases (APH) - catalyses ATP-dependent phosphorylation of a hydroxyl group 
O-fosfotransferaza (APH) - katalizira fosforilacijo hidroksilne kisline, odvisno od ATP.
Cattle, horses (non-food producing), pigs, dogs and cats 
govedo, konji (ki niso namenjeni za proizvodnjo živil), prašiči, psi in mačke
O-Adenyltransferases (ANT) - catalyses ATP-dependent adenylation of hydroxyl group 
O-adeniltransferaza (ANT) - katalizira adenilacijo hidroksilne kisline, odvisno od ATP;
N-Acetyltransferases (AAC) - catalyses acetyl CoA-dependent acetylation of an amino group 
N-acetiltransferaza (AAC) - katalizira acetilacijo aminoskupine, odvisno od acetilkoencima;
4.2 Indications for use, specifying the target species For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin. 
Indikacije za uporabo pri ciljnih živalskih vrstah Za zdravljenje okužb spodnjih dihal pri konjih, ki jih povzročajo aerobne gramnegativne bakterije, občutljive za gentamicin.
Estonia Interchemie werken "De Adelaar" Eesti AS 
Estonija Interchemie werken "De Adelaar" Eesti AS Vanapere tee 14, Pringi 74001 Viimsi Harjumaa Estonija
Spain Laboratorios e Industrias IVEN, S.A. 
Španija Laboratorios e Industrias IVEN, S.A. Polígono Industrial de Vallecas.
10000 Zagreb 
Radnička cesta 48 10000 Zagreb Hrvaška
Spain LABORATORIOS MAYMO, S.A. 
Španija LABORATORIOS MAYMO, S.A. Via Augusta, 302
Ozzano Emília Bologna 
Via Emilia 285 Ozzano Emília Bologna Italija
As such, no margin of safety has been established in neonatal foals. 
Posledično terapevtski indeks pri novorojenih žrebetih ni bil določen.
Nephrotoxicity is the main risk to the target animal from gentamicin that could occur within therapeutic doses. 
Glavno tveganje za ciljne živali, povezano z gentamicinom, ki se lahko pojavi pri terapevtskih odmerkih, je nefrotoksičnost.
Cattle, pig, horse declared as not being intended for slaugther for human consumption, cat, dog 
govedo, prašiči, konji, ki niso namenjeni za zakol za prehrano ljudi, mačke, psi
Non foodproducing horses, cattle and pigs 
konji, ki niso namenjeni za proizvodnjo živil, govedo in prašiči
Gentaject 10% Solution for Injection 
Gentaject 10% Solution for Injection konji, ki niso namenjeni za zakol za prehrano ljudi
The dosing regimen must not be exceeded.” The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses negative for use in foals. 
Odbor CVMP je menil, da je razmerje med tveganji in koristmi zdravil za injiciranje za uporabo v veterinarski medicini, ki vsebujejo gentamicin in se uporabljajo pri konjih, negativno pri uporabi za žrebeta.
Equine not intended for human consumption, dogs, cats 
konji, ki niso namenjeni za prehrano ljudi, psi, mačke
Horses, cattle, dogs and cats 
konji, govedo, psi in mačke
The CVMP also considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive when the posology for adult horses (with appropriate warnings and advice on dosing) is changed to: “Single dose of 6.6 mg/kg bw given intravenously once daily for 3-5 consecutive days. 
Odbor CVMP je prav tako menil, da je razmerje med tveganji in koristmi zdravil za injiciranje za uporabo v veterinarski medicini, ki vsebujejo gentamicin in se uporabljajo pri konjih, pozitivno, če se odmerjanje za odrasle konje (z ustreznimi opozorili in nasveti za odmerjanje) spremeni, kot sledi:
Horses (non-food producing) 
Gentamicin konji (ki niso namenjeni za proizvodnjo živil)
4.1 Target species Horses (non food-producing horses). 
Ciljne živalske vrste Konji (ki niso namenjeni za proizvodnjo živil).
Germany Bela-Pharm GmbH & Co. KG Lohner Str. 19 
Nemčija Bela-Pharm GmbH & Co.
Horses (non food producing horse). 
Konji (ki niso namenjeni za proizvodnjo živil).
Non foodproducing horses, cattle, pigs, dogs and cats 
konji, ki niso namenjeni za proizvodnjo živil, govedo, prašiči, psi in mačke
Cattle, pigs, horses, dogs, cats 
govedo, prašiči, konji, psi, mačke
Non foodproducing horses, cattle, dogs and cats 
konji, ki niso namenjeni za proizvodnjo živil, govedo, psi in mačke
As such, gentamicin has a narrow margin of safety. 
Posledično ima gentamicin ozek terapevtski indeks.
Cats, cattle, dogs, horses 
mačke, govedo, psi, konji
C/ Luis I s/n. 
C/ Luis I s/n. 28031 Madrid Španija
Pigs, cattle, dogs, horses 
prašiči, govedo, psi, konji
Horse, foal, cattle, calf, pig, piglet, weaner, dog and cat 
konji, žrebeta, govedo, teleta, prašiči, prašički, odstavljenci, psi in mačke
Pigs, cats, cattle, dogs, horses 
prašiči, mačke, govedo, psi, konji
Horses, cattle, pigs, dogs and cats 
Gentamicin konji, govedo, prašiči, psi in mačke
Iceland Franklin Pharmaceuticals Ltd. Athboy Road 
Islandija Franklin Pharmaceuticals Ltd. Athboy Road
Sweden Franklin Pharmaceuticals Ltd. Athboy Road 
Švedska Franklin Pharmaceuticals Ltd. Athboy Road
Estonia 
Latvija
The CVMP considered the benefit-risk balance for injectable veterinary medicinal products containing gentamicin for horses positive for the following indication: “For the treatment of infections of the lower respiratory tract in horses caused by Gram-negative bacteria susceptible to gentamicin.” 
Odbor CVMP je menil, da je razmerje med tveganji in koristmi zdravil za injiciranje za uporabo v veterinarski medicini, ki vsebujejo gentamicin in se uporabljajo pri konjih, pozitivno za naslednjo indikacijo:
Spain Franklin Pharmaceuticals Ltd. Athboy Road 
Španija Franklin Pharmaceuticals Ltd. Athboy Road
4.5 Special precautions for use 
Posebni previdnostni ukrepi
Cattle, horse, swine 
Gentamicin govedo, konji, svinje
Dog, cat, pig, piglets, cattle, calves, horses 
Gentamicin psi, mačke, prašiči, prašički, govedo, teleta, konji
Italy 
Belgija
Cattle, horses, dogs and cats 
Gentamicin govedo, konji, psi in mačke
Horses (non food producing horses) 
Genta Equine konji (ki niso namenjeni za proizvodnjo živil)
Harjumaa 
Jakost
Intramuscular Type I hydrolytic glass vial with butyl stopper and aluminium seal. 
Intramuskularno Hidrolitična steklena viala tipa I z butilnim zamaškom zaščitenim z aluminijasto kapico.
Intramuscular Type II hydrolytic glass vial with butyl stopper and aluminium seal 
Intramuskularno Hidrolitična steklena viala tipa II z butilnim zamaškom zaščitenim z aluminijasto kapico.
The European Commission granted a marketing authorisation valid throughout the European Union for Arixtra on 21 March 2002. 
Evropska komisija je dovoljenje za promet z zdravilom Arixtra, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2002.
The dose may be adjusted depending on body weight. 
Odmerek se lahko prilagodi, odvisno od telesne mase.
Other information about Arixtra: 
Druge informacije o zdravilu Arixtra:
For patients having surgery, the first dose should be given six hours after the end of the operation. 
Bolnikom po operaciji se začetni odmerek da šest ur po koncu operacije.
Arixtra fondaparinux sodium 
Arixtra natrijev fondaparinuks
This document is a summary of the European public assessment report (EPAR) for Arixtra. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Arixtra.
Blood clotting can be a problem when blood flow is disturbed in any way. 
Strjevanje krvi lahko predstavlja resno težavo, če je pretok krvi kakor koli oviran.
The CHMP decided that Arixtra's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Arixtra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Arixtra shown during the studies? 
Kakšne koristi je zdravilo Arixtra izkazalo med študijami?
In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots). 
V vseh študijah je bilo glavno merilo učinkovitosti celokupna stopnja trombotičnih dogodkov (zapletov zaradi krvnih strdkov).
Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days. 
Zdravljenje je treba začeti čim prej po izključitvi možnosti nastanka globoke venske tromboze in ga je treba nadaljevati od 30 do 45 dni.
For patients who have kidney problems, Arixtra may not be suitable, or the 1.5-mg dose may be used. 
Za bolnike, ki imajo težave s ledvicami, zdravilo Arixtra morda ni ustrezno oziroma se lahko uporabi 1,5-miligramski odmerek.
It can also be used in adults at high risk (because of their age or disease) when they are having abdominal surgery or are forced to stay in bed because of an acute illness. 
Prav tako se lahko uporablja pri bolnikih, pri katerih obstaja povečano tveganje (zaradi njihove starosti ali bolezni) pri kirurških posegih v trebušni votlini ali pri bolnikih, ki so morajo ostati v postelji zaradi akutne bolezni.
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 Arixtra. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Arixtra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For more information about treatment with Arixtra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Arixtra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
However, these results were insufficient to show whether Arixtra was more effective than unfractionated heparin or not. 
Vendar ti rezultati niso bili zadostni, da bi pokazali, da je zdravilo Arixtra učinkovitejše od nefrakcioniranega heparina.
As with other anticoagulant medicines, the most common side effect of Arixtra is bleeding. 
Kot pri vseh drugih antikoagulacijskih zdravilih je najpogostejši neželeni učinek zdravila Arixtra krvavenje.
Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery. 
Zdravljenje je treba nadaljevati, dokler se tveganje za vensko tromboembolične dogodke ne zmanjša, navadno vsaj pet do devet dni po operaciji.
By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced. 
Z uporabo zdravila Arixtra po operaciji se tveganje za nastanek krvnih strdkov močno zmanjša.
When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed. 
Če je ta zaviran, se trombin (drugi faktor) ne more več tvoriti, zaradi česar tudi krvni strdki ne morejo več nastajati.
What is the risk associated with Arixtra? 
Kakšna tveganja so povezana z zdravilom Arixtra?
Arixtra is a solution for injection in a prefilled syringe. 
Zdravilo Arixtra je raztopina za injiciranje v napolnjeni injekcijski brizgi.
Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting). 
Zdravilo Arixtra je antikoagulant: preprečuje koagulacijo (strjevanje) krvi.
Arixtra has also been studied in two main studies of patients with unstable angina or myocardial infarction. 
Zdravilo Arixtra so tudi raziskovali v dveh glavnih študijah bolnikov z nestabilno angino pektoris ali miokardnim infarktom.
For the full list of all side effects reported with Arixtra, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Arixtra, glejte navodilo za uporabo.
The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, factor Xa. 
Zdravilna učinkovina zdravila Arixtra, natrijev fondaparinuks, zavira eno od snovi (faktorjev), ki sodelujejo pri strjevanju krvi, in sicer faktor Xa.
In the study of myocardial infarction with ST segment elevation, Arixtra reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care. 
Pri študiji miokardnega infarkta z dvigom spojnice ST je zdravilo Arixtra v primerjavi s standardnim zdravljenjem po 30 dneh zmanjšalo tveganje smrti ali ponovnega srčnega napada za 14 %.
Arixtra was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days. 
Zdravilo Arixtra je bilo vsaj toliko učinkovito kot enoksaparin pri preprečevanju smrti ali ishemičnih dogodkov pri bolnikih z nestabilno angino pektoris ali miokardnim infarktom z dvigom spojnice ST, pri čemer je po devetih dneh približno 5 % bolnikov v vsaki skupini umrlo ali imelo ishemični dogodek.
Why has Arixtra been approved? 
Zakaj je bilo zdravilo Arixtra odobreno?
Arixtra is not recommended in patients who are about to undergo certain types of operations to unblock the heart's blood vessels. 
Zdravilo Arixtra se ne priporoča bolnikom, pri katerih bodo izvedene določene vrste kirurških posegov za odmašitev srčnih krvnih žil.
Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe). 
Zdravilo vsebuje zdravilno učinkovino natrijev fondaparinuks (1,5 mg, 2,5 mg, 5 mg, 7,5 mg ali 10 mg na brizgo).
By reducing blood clots, Arixtra can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack. 
Poleg zmanjševanja nastanka krvnih strdkov lahko zdravilo Arixtra pomaga bolnikom z angino pektoris ali bolnikom, ki imajo srčni napad, da ohranijo enak pretok krvi v srce.
The main measure of effectiveness of this study was the overall occurrence of VTE or death. 
Glavno merilo učinkovitosti študije je bil celokupni pojav venskih tromboemboličnih dogodkov ali smrti.
Arixtra should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems. 
Zdravila Arixtra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev fondaparinuks ali katero koli drugo sestavino zdravila, ter osebe, ki krvavijo ali imajo akutni bakterijski endokarditis (okužbo srca) ali hude težave z ledvicami.
The 2.5 mg strength is also used to treat adults with unstable angina (a type of chest pain that changes in severity due to reduced blood flow to the heart) or who are having a myocardial infarction (heart attack) with or without ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG). 
2,5-miligramski odmerek se uporablja tudi za zdravljenje odraslih ljudi z nestabilno angino pektoris (vrsto bolečine v prsih, katere jakost se spreminja zaradi zmanjšanega dotoka krvi v srce) ali miokardnim infarktom (srčnim napadom) z „dvigom spojnice ST“ (nenormalnim izpisom na elektrokardiogramu ali EKG-ju) ali brez njega.
In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients). 
V študijah za preprečevanje bolezni so zdravilo Arixtra primerjali z drugimi antikoagulanti: enoksaparinom (pri operacijah kolka ali kolena; več kot 8 000 bolnikov) ali dalteparinom (pri operacijah v trebušni votlini; 2 972 bolnikov).
The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin. 
Skupna stopnja trombotičnih dogodkov pri bolnikih, zdravljenih z zdravilom Arixtra, je bila znatno manjša kot pri bolnikih, zdravljenih s placebom ali enoksaparinom (pri bolnikih, operiranih na nogah), oziroma je bila podobna tisti, ugotovljeni pri uporabi enoksaparina (pri zdravljenju globoke venske tromboze), dalteparina ali nefrakcioniranega heparina.