natgillin/translations-raw huggingface dataset:
• Screw the pre-filled pen together until the clear front part and the pen body meet. 
• Privijte napolnjen injekcijski peresnik do konca, dokler se prozorni sprednji del ne spoji s telesom peresnika.
• Put the pre-filled pen back into the refrigerator immediately after you have used it. 
• Napolnjen injekcijski peresnik po uporabi nemudoma znova shranite v hladilniku.
No dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30 to 80 ml/min). 
Pri bolnicah z blago do zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/min) ni treba prilagajati odmerka.
• Keep Preotact protected from light 
• Zdravilo Preotact shranjujte zaščiteno pred svetlobo.
Keep this medicine out of sight and reach of children. 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
• citric acid monohydrate, 
• citronsko kislino monohidrat
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone 
IME ZDRAVILA IN POT(I) UPORABE Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje obščitnični hormon subkutana uporaba
The fragments derived from the amino-terminus are further degraded within the cell while the fragments derived from the carboxy-terminius are released back into the blood and cleared by the kidney. 
Fragmenti, ki izhajajo iz karboksi-konca, pa se sproščajo nazaj v kri in se očistijo v ledvicah.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. 
Če bolnice s prehrano ne zaužijejo zadosti kalcija in vitamina D, morajo prejemati dodatke teh snovi.
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
In response to subcutaneous doses of Preotact (100 micrograms parathyroid hormone), serum total calcium levels increase gradually and reach peak concentration (mean increase in 129 patients, 0.15 mmol/l) at approximately 6 to 8 hours after dosing. 
Kot odziv na podkožno injicirane odmerke zdravila Preotact (100 µg obščitničnega hormona), se postopno višajo serumske koncentracije celokupnega kalcija in dosežejo najvišjo koncentracijo (povprečno zvišanje pri 129
Infections and infestations Uncommon 
Infekcijske in parazitske bolezni
Pre-filled pen (before reconstitution): Do not store above 25°C. 
POSEBNA NAVODILA ZA SHRANJEVANJE Napolnjen injekcijski peresnik (pred pripravo): Shranjujte pri temperaturi do 25 °C.
Press the yellow release button to release the blue injection button. 
Pritisnite rumeni sprožilni gumb, s čimer sprostite modri injekcijski gumb.
The first chamber contains 1.61 mg parathyroid hormone as powder and the second chamber contains 1.13 ml of solvent. 
Prva komora vsebuje 1,61 mg obščitničničnega hormona v obliki praška in druga komora vsebuje1,13 ml vehikla.
• with unexplained elevations of bone-specific alkaline phosphatase 
• z zvišanimi ravnmi za kosti značilne alkalne fosfataze brez ugotovljenega vzroka
The table below gives an overview of the ADRs where the incidence is at least 0.5% higher in the parathyroid hormone group compared to placebo. 
V spodnji preglednici je pregled neželenih učinkov, kjer je bila pojavnost v skupini bolnic, ki so prejemale obščitnični hormon za 0,5% višja kot v skupini bolnic, ki so prejemale placebo.
• increased level of alkaline phosphatase in the blood , 
• zvišana raven alkalne fosfataze v krvi,
Do not use Preotact after the expiry date which is stated on the pre-filled pen and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na napolnjenem injekcijskem peresniku in na škatlici poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
• hydrochloric acid, 
• klorovodikovo kislino
Treatment of osteoporosis with combination and sequential therapy The PaTH study was a National Institute of Health (NIH) sponsored randomised, placebo-controlled, 2 year, multicenter, double-blind trial of Preotact and alendronate as monotherapy and in combination for the treatment of postmenopausal osteoporosis. 
Šlo je za dveletno, randomizirano, s placebom nadzorovano, multicentrično, dvojno slepo preskušanje zdravila Preotact in alendronata za zdravljenje pomenopavzne osteoporoze v monoterapiji ali v kombinaciji.
Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen. 
Držite prozorni sprednji del napolnjenega injekcijskega peresnika in do konca privijte iglo na prozorni sprednji del napolnjenega injkecijskega peresnika.
• Release residual air (prime the pen) 
• Sprostite odvečen zrak (pripravite peresnik)
There was a modest increase of about 20% in the mean baseline corrected exposure (AUC) to parathyroid hormone in a study conducted in 6 men and 6 women with moderate hepatic impairment as compared with a matched group of 12 subjects with normal hepatic function. 
V študiji pri 6 moških in 6 ženskah z zmerno okvaro jeter so odkrili manjše (približno 20%) zvišanje za povprečno osnovnico popravljene izpostavitve (AUC) obščitničnemu hormonu v primerjavi z ujemajočo se skupino 12 preiskovancev z normalno jetrno funkcijo.
Keep the product protected from light. 
Zdravilo shranjujte zaščiteno pred svetlobo.
The increase from baseline in lumbar spine and femoral neck BMD was 6.8% and 2.2%, respectively in patients treated with Preotact. 
Pri bolnicah, zdravljenih z zdravilom Preotact, se je BMD ledvenega predela hrbtenice povečal za 6,8%, BMD femoralnega vratu pa za 2,2% nad izhodiščnimi vrednostmi.
4.9 Overdose 
4.9 Preveliko odmerjanje Znaki in simptomi
After reconstitution, each dose of 71.4 microlitre contains 100 micrograms parathyroid hormone produced in Escherichia coli by recombinant DNA technology For a full list of excipients, see section 6.1. 
Po rekonstituciji en odmerek z 71,4 mikrolitri vsebuje 100 mikrogramov obščitničnega hormona, ki je pridobljen v Escherichia coli s tehnologijo rekombinantne DNA.
• Do not store the pre-filled pen with the needle on. 
• Ne shranjujte napolnjenega injekcijskega peresnika z nataknjeno iglo.
Significant increases in hip BMD (total, femoral neck, trochanter) were observed at study endpoint; 1.0, 1.8 and 1.0%, respectively, for Preotact versus -1.1,0.7 and -0.6% for placebo (p<0.001). 
Pri merjenju ciljev študije so opazili statistično značilno povečanje BMD kolka, in sicer v skupini bolnic, ki so prejemale zdravilo Preotact: skupno 1,0%, v femoralnem vratu 1,8%, v trohantru 1,0%, v primerjavi s skupino bolnic, ki so prejemale placebo: skupno -1,1%, v femoralnem vratu -0,7%, v trohantru -0,6% (p<0,001).
No dose adjustment is needed for patients with mild or moderate hepatic impairment (total score of 7 to 9 on the Child-Pugh scale). 
Pri bolnicah z blago do zmerno okvaro jeter (skupno število točk po lestvici Child-Pugh od 7 do 9) ni treba prilagajati odmerka.
Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen Parathyroid hormone 
Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku obščitnični hormon
Do not use Preotact • if you are allergic to parathyroid hormone or any of the other ingredients of this medicine (listed 
• če ste alergični na obščitnični hormon ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Elevated serum calcium was observed during Preotact treatment. 
Med zdravljenjem z zdravilom Preotact so opazili zvišane serumske ravni kalcija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničnega hormona, kar ustreza 14 odmerkom.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP. 
načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Volumetric trabecular BMD at the lumbar spine increased by 26, 13, and 11% (Preotact, Preotact and alendronate and alendronate, respectively) over baseline at 12 months. 
Volumetrični trabekularni BMD v ledvenem predelu hrbtenice se je od izhodiščnih vrednosti v 12 mesecih povečal za 26% v skupini, ki je prejemala zdravilo Preotact, za 13% v skupini, ki je prejemala zdravilo Preotact in alendronat, in za 11% v skupini, ki je prejemala alendronat.
• You can store the mixed pre-filled pen for up to 7 days at room temperature, between 2-25°C. 
• Napolnjen injekcijski peresnik z zmešanim zdravilom lahko shranjujete do 7 dni pri sobni temperaturi od 2 °C- 25 °C.
Pre-filled pen(after reconstitution): Store in a refrigerator (2-8°C). 
Napolnjen injekcijski peresnik (po pripravi): Shranjujte v hladilniku (2 °C - 8 °C).
Preotact is a powder and solvent for solution for injection in a pre-filled pen. 
Zdravilo Preotact je prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled pen 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
• Ensure that you have a needle on the pre-filled pen (see pictures 3 and 4). 
(glejte sliki 3 in 4).
• constipation, diarrhoea, 
• zaprtost, driska,
Reconstituted solution: Store in a refrigerator (2-8°C). 
Pripravljena raztopina: Shranjujte v hladilniku (2 °C - 8 °C).
Every day you have to check that the medicine is clear, add a new needle, take the injection in your abdomen and then throw away the needle before storing your pre-filled pen in the refrigerator (2-8°C). 
Vsak dan morate preveriti, če je zdravilo bistro, dodati novo iglo, se zbosti v trebuh in nato zavreči iglo,
• increased level of calcium in the blood, 
• zvišana raven kalcija v krvi,
The pre-filled pen after mixing: 
Napolnjen injekcijski peresnik po mešanju:
Increases in BMD at the total hip were 0.3, 1.9, and 3.0% for the 3 groups, respectively. 
Povečki BMD celotnega kolka so bili 1,9% v prvi omenjeni skupini,
Pinch a skin fold in the abdomen and take the injection in a 90° degree angle as you have been instructed by your doctor or nurse. 
S prsti stisnite kožno gubo na trebuhu in naredite vbod z injekcijsko iglo pod kotom 90°,
Langebjerg 1, 4000 Roskilde 
Nycomed Danmark ApS Langebjerg 1, 4000 Roskilde Danska
• stomach upset, vomiting, 
• razdražen želodec, bruhanje, • utrujenost.
• sodium chloride, 
• natrijev klorid
Parathyroid hormone is efficiently removed from the blood by a receptor-mediated process in the liver and is broken down into smaller peptide fragments. 
Obščitnični hormon se v jetrih učinkovito odstranjuje iz krvi s procesi, ki jih posredujejo receptorji,
Preotact is available in packs of 2 pre-filled pens. 
Zdravilo je na voljo v pakiranju z 2 napolnjenima injekcijskima peresnikoma.
Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time. 
Ko je raztopina v vložku pripravljena, lahko zdravilo shranjujete pri temperaturi do 25 °C do 7 dni v 28-dnevnem obdobju uporabnosti.
Ask your doctor or pharmacist for advice before taking any medicine Do not use Preotact if you are pregnant or breast-feeding. 
Če ste noseči ali če dojite, ne uporabljajte zdravila Preotact.
There are no data available from the use of parathyroid hormone in women of childbearing potential, during pregnancy and breast feeding. 
4.6 Plodnost, nosečnost in dojenje Ni podatkov o uporabi obščitničnega hormona pri ženskah v rodni dobi, med nosečnostjo in med dojenjem.
Each cartridge inside the prefilled pen contains 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses). 
En vložek znotraj napolnjenega injekcijskega peresnika vsebuje po 1,61 mg obščitničnega hormona in 1,13 ml vehikla (14 odmerkov).
Injection site irritation 
Eritem na mestu injiciranja Utrujenost
Clinical efficacy 
KLINIČNI PODATKI
The following adverse reaction (ADR) data are based on two placebo-controlled studies involving 2,642 postmenopausal osteoporotic women of whom 1,341 received parathyroid hormone. 
študiji so vključili 2642 pomenopavznih žensk z osteoporozo, od katerih jih je 1341 prejemalo obščitnični hormon.
There is no data available in patients with severe hepatic impairment. 
O odmerjanju pri bolnicah s hudo okvaro jeter ni podatkov.
• increased level of calcium in the urine, 
• zvišana raven kalcija v urinu,
• suffer from kidney stones; 
• imate ledvične kamne,
Measuring of the calcium levels in the blood and/or urine Your doctor will check your response to the treatment at regular intervals. 
Vaš zdravnik bo v rednih časovnih presledkih preverjal odziv na zdravljenje.
Preotact is available in a pack with 2 pre-filled pens. 
Zdravilo je na voljo v pakiranju, ki vsebuje 2 napolnjena injekcijska peresnika.
The medicinal product is supplied in a pre-filled pen containing a dual-chamber cartridge. 
Zdravilo je na voljo v napolnjenem injekcijskem peresniku, ki vsebuje en vložek z dvema komoroma.
Preotact should be used with caution in patients with active or previous urolithiasis. 
Zdravilo Preotact moramo pri bolnicah z aktivno urolitiazo ali anamnezo te bolezni uporabljati previdno.
Dysgeusia 
Dizgevzija Parozmija
Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses. 
En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničnega hormona, kar ustreza 14 odmerkom.
Injection site erythema 
Draženje na mestu injiciranja
LIST OF EXCIPIENTS 
Števec odmerkov
Pull the cap straight off from the front end of the pre-filled pen. 
Povlecite in odstranite pokrov s sprednjega dela napolnjenega injekcijskega peresnika.
The volume of distribution at steady-state following intravenous administration is approximately 5.4 l. Interindividual variability in the volume of distribution of parathyroid hormone is about 40%. 
Interindividualna variabilnost volumna porazdelitve obščitničnega hormona je približno 40%.
Parosmia 
SERIJE
• increased level of uric acid in the blood, 
• zvišana raven sečne kisline v krvi,
Wash your hands with soap and water before you handle the pre-filled pen. 
Pred rokovanjem z napolnjenim injekcijskim peresnikom si umijte roke z vodo in milom.
In the pivotal study, Preotact increased BMD in the lumbar spine after 18 months treatment by 6.5% compared with -0.3% for placebo (p<0.001). 
6,5% v primerjavi z -0,3% pri bolnicah, ki so prejemale placebo (p<0,001).
• You can store the mixed pre-filled pen for up to 7 days outside the refrigerator (below 25°C) 
• Pripravljen napolnjen injekcijski peresnik lahko shranjujete izven hladilnika (pri temperaturi do 25 °C) največ do 7 dni v 28-dnevnem obdobju uporabnosti.
Keep the pre-filled pen in the outer carton in order to protect from light. 
Za zagotovitev zaščite pred svetlobo shranjujte napolnjen injekcijski peresnik v zunanji škatli.
What you need to know before you use Preotact 
Kaj morate vedeti, preden boste uporabili zdravilo Preotact Ne uporabljajte zdravila Preotact:
Hepatic impairment 
Pogosti Glavobol Omotica
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses) 
1,61 mg obščitničnega hormona in 1,13 ml vehikla (14 odmerkov)
Asthenia 
Zdravilo
Vomiting 
Vehikel
Posology The recommended dose is 100 micrograms of parathyroid hormone administered once-daily 
Priporočeni odmerek je 100 µg obščitničnega hormona enkrat dnevno.
METHOD AND ROUTE(S) OF ADMINISTRATION Do not shake the reconstituted solution Read the package leaflet before use Subcutaneous use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pripravljene raztopine ne stresajte.
Talk to your doctor or pharmacist before using Preotact if you: 
Pred začetkom uporabe zdravila Preotact se posvetujte s svojim zdravnikom ali s farmacevtom, če
Check with your doctor or pharmacist if you are not sure. 
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
2 pre-filled pens per pack. 
škatla z 2 napolnjenima injekcijskima peresnikoma
Name and address of the manufacturer responsible for batch release Nycomed Danmark ApS 
Ime in naslov izdelovalca, odgovornega za sproščanje serije
• abdominal pain, 
• bolečine v trebuhu,
• with severe hepatic impairment 
• s hudimi okvarami ledvic • s hudimi okvarami jeter
Please see how to use the pen in the Instructions for use manual. 
Navodilo za uporabo peresnika si, prosimo, oglejte v priloženem navodilu.
Lot 
Spol
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničnega hormona, kar ustreza 14 odmerkom.
Gastrointestinal disorders Very common 
Zelo pogosti Hiperkalciurija
Each pre-filled pen contains 1.61 mg of parathyroid hormone as powder and 1.13 ml of solvent. 
En napolnjen injekcijski peresnik vsebuje 1,61 mg obščitničničnega hormona v obliki praška in
• Take the daily injection • Store the pre-filled pen 
• Vzamete dnevno injekcijo
The steps you have to go through with a new pre-filled pen: 
Z novim napolnjenim injekcijskim peresnikom morate opraviti naslednje korake:
Antibodies to parathyroid hormone 
Obščitnični hormon
Blood alkaline phosphatase increased Anorexia 
Zvišana vrednost alkalne fosfataze v krvi
NAME OF THE MEDICINAL PRODUCT Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen. 
Preotact 100 mikrogramov prašek in vehikel za raztopino za injiciranje v napolnjenem injekcijskem peresniku
What Preotact contains -The active substance is parathyroid hormone. 
-Zdravilna učinkovina je obščitnični hormon.
This overview was last updated in 09-2014. 
Pregled je bil nazadnje posodobljen 09-2014.
Further information on Eliquis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Nadaljnje informacije za zdravilo Eliquis so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is available as tablets (2.5 mg, 5 mg). 
Na voljo je v obliki tablet (2,5 in 5 mg).
Thrombin is central to the process of blood clotting. 
Trombin ima osrednjo vlogo v postopku strjevanja krvi.
The European Medicines Agency decided that Eliquis' benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Eliquis večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Eliquis received a marketing authorisation valid throughout the EU on 18 May 2011. 
Za zdravilo Eliquis je bilo 18. maja 2011 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Eliquis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Eliquis?
As for all medicines, data on the use of Eliquis are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Eliquis stalno spremljajo.
Other information about Eliquis 
Druge informacije o zdravilu Eliquis
For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation. 
Pri bolnikih po kirurški zamenjavi kolka ali kolena je treba zdravljenje z zdravilom Eliquis začeti od 12 do 24 ur po operaciji.
For more information about using Eliquis, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Eliquis glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month (32 to 38 days) after a hip replacement or for 10 to 14 days after a knee replacement. 
Priporočeni odmerek je ena 2,5-miligramska tableta; jemlje se dvakrat na dan peroralno, običajno več kot en mesec (od 32 do 38 dni) po kirurški zamenjavi kolka oziroma od 10 do 14 dni po kirurški zamenjavi kolena.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eliquis have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Eliquis upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What benefits of Eliquis have been shown in studies? 
Kakšne koristi zdravila Eliquis so se pokazale v študijah?
It is used in patients who have one or more risk factors, such as having had a previous stroke, having high blood pressure, diabetes, heart failure or being 75 years old or over. 
Uporablja se pri bolnikih z enim ali več dejavniki tveganja, kot so možganska kap v preteklosti, visok krvni tlak, sladkorna bolezen, srčno popuščanje ali starost 75 let ali več.
The most frequent side effects with Eliquis (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), haematoma (a collection of blood under the skin), contusion (bruising), nausea (feeling sick), low blood pressure (hypotension), epistaxis (nose bleeds), haematuria (blood in urine), low blood platelet counts (thrombocytopenia), blood tests showing alanine aminotransferase and gamma-glutamyltransferase increase and skin rash. 
Najpogostejši neželeni učinki zdravila (opaženi pri 1 do 10 od 100 bolnikov) so anemija (nizko število rdečih krvnih celic), krvavitve, hematom (izliv krvi pod kožo), podplutbe, navzea (siljenje na bruhanje), nizek krvni tlak (hipotenzija), epistaksa (krvavitve iz nosu), hematurija (kri v urinu), nizko število trombocitov (trombocitopenija), krvni testi, ki kažejo zvišane ravni alanin-aminotransferaze in gama-glutamiltransferaze, ter kožni izpuščaji.
Why is Eliquis authorised in the EU? 
Zakaj je bilo zdravilo Eliquis odobreno v EU?
The company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment. 
Podjetje, ki trži zdravilo Eliquis, bo priskrbelo izobraževalno gradivo za zdravstvene delavce, ki bodo predvidoma predpisovali zdravilo Eliquis, in v njem opisalo tveganja za krvavitve med zdravljenjem.
An overview of Eliquis and why it is authorised in the EU 
Pregled zdravila Eliquis in zakaj je odobreno v EU
Side effects reported with Eliquis are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Eliquis, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
Similarly, patients with atrial fibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke. 
Podobno pri bolnikih z atrijsko fibrilacijo obstaja veliko tveganje za nastanek strdkov v srcu; ti strdki lahko pridejo v možgane in povzročijo možgansko kap.
In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots). 
V obeh študijah so zdravilo Eliquis primerjali z enoksaparinom (drugim zdravilom za preprečevanje krvnih strdkov).
Some of these side effects are not seen with all the uses of Eliquis. 
Nekateri od teh neželenih učinkov se ne pojavijo pri vseh načinih uporabe zdravila Eliquis.
The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances (see summary of product characteristics). 
Zdravilo se prav tako ne sme uporabljati pri bolnikih z boleznimi, zaradi katerih pri njih obstaja tveganje za večje krvavitve, kot so razjede v črevesju, ali bolnikih, ki prejemajo druga antikoagulacijska zdravila, razen v posebnih okoliščinah (glejte povzetek glavnih značilnosti zdravila).