natgillin/translations-raw huggingface dataset:
87 Danmark Boehringer Ingelheim Danmark A/ S Tlf: +45 39 15 88 88 Deutschland Boehringer Ingelheim Pharma GmbH & Co.
Tel: +31 30 6 02 59 14 Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00 Österreich Boehringer Ingelheim Austria GmbH Tel: +43 1 710 3739 Polska Boehringer Ingelheim Sp. z o. o.
KG Tel: +49 (0) 69 50 50 83 09 Eesti Boehringer Ingelheim Pharma GmbH Tel: + 37 2 60 80 940 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε.
84
ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
85 NAVODILO ZA UPORABO ARICLAIM 30 mg trde gastrorezistentne kapsule ARICLAIM 60 mg trde gastrorezistentne kapsule duloksetin (v obliki klorida)
Do not pass it on to others.
Njim bi lahko celo
Possible side effects 5 How to store ARICLAIM 6.
Možni neželeni učinki 5 Shranjevanje zdravila ARICLAIM 6.
ARICLAIM is used in adults to treat a condition called diabetic neuropathic pain.
Zdravilo ARICLAIM se uporablja za lajšanje bolečine pri diabetični nevropatiji pri odraslih.
BEFORE YOU TAKE ARICLAIM
Ne jemljite zdravila ARICLAIM
Do not take ARICLAIM − If you are allergic (hypersensitive) to duloxetine or any of the other ingredients of ARICLAIM. − If you are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘ Taking other medicines’). − If you have liver disease. − If you have severe kidney disease. − If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections. − If you suffer from uncontrolled high blood pressure.
- Če jemljete ali ste v zadnjih 14 dneh jemali drugo antidepresivno zdravilo, imenovano zaviralec
Take special care with ARICLAIM The following are reasons why ARICLAIM may not be suitable for you.
monoaminooksidaze (MAOI) (glejte tudi v nadaljevanju v poglavju ‘ Jemanje drugih zdravil ’).
If any of them apply to you, talk to your doctor before you take the medicine:
- Če jemljete fluvoksamin, ki se običajno uporablja za zdravljenje depresije, ciprofloksacin ali
- You are taking other medicines to treat depression.
enoksacin, ki se uporablja za zdravljenje nekaterih okužb.
- You are taking a herbal treatment containing St.
- Če imate nenadzorovan visok krvni tlak.
John’ s Wort (Hypericum perforatum).
- Jemljete druga zdravila za zdravljenje depresije.
89
- Jemljete pripravke rastlinkega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
- You have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
- Imate težave z očmi, denimo določene vrste glavkoma (povišan tlak v očesu).
- You have a history of bleeding disorders (tendency to develop bruises).
- Imeli ste motnje strjevanja krvi (nagnjenost k pojavu podplutb).
Use in children and adolescents under 18 years of age ARICLAIM should normally not be used for children and adolescents under 18 years.
Uporaba pri otrocih in mladostnikih, mlajših od 18 let Zdravila ARICLAIM pri otrocih in mladostnikih, mlajših od 18 let, običajno ne uporabljamo.
Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/ she decides that this is in their best interests.
Temu navkljub lahko vaš zdravnik predpiše zdravilo ARICLAIM tudi bolnikom, mlajšim od 18 let, če se odloči, da je to v njihovo najboljšo korist.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions (depression and urinary incontinence).
Poglavitno sestavino zdravila ARICLAIM, duloksetin, uporabljamo tudi v drugih zdravilih za zdravljenje drugih bolezni (depresije in urinske inkontinence).
Monoamine Oxidase Inhibitors (MAOIs):
Zaviralci monoaminooksidaze (MAOI):
You should not take ARICLAIM if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Zdravila ARICLAIM ne smete jemati, če jemljete ali ste v zadnjih 14 dneh vzeli drugo antidepresivno zdravilo, imenovano zaviralec monoaminooksidaze (MAOI).
You must wait at least 14 days
Po prenehanju jemanja MAOI morate počakati vsaj 14 dni, preden lahko vzamete zdravilo ARICLAIM.
Medicines that cause sleepiness:
87 Zdravila, ki povzročajo zaspanost:
Tell your doctor if you are taking any medicines which cause you to be sleepy.
Povejte svojemu zdravniku, če jemljete kakršnakoli zdravila, ki vam povzročajo občutek zaspanosti.
These would include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, antihistamines.
Taka zdravila vam je lahko predpisal vaš zdravnik, med njimi so, denimo, benzodiazepini, močna zdravila proti bolečinam, antipsihotiki, fenobarbital, antihistaminiki.
Serotonin syndrome: you should tell your doctor if you are taking any of the medicines that act in a similar way to duloxetine.
Če jemljete katero od zdravil, ki delujejo na podoben način kot duloksetin, morate to povedati svojemu zdravniku.
Examples of these medicines include: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’ s Wort and venlafaxine.
Taka zdravila so denimo: triptani, tramadol, triptofan, SSRI (kot sta paroksetin in fluoksetin), triciklični antidepresivi (kot sta klomipramin, amitriptilin), petidin, šentjanževka in venlafaksin.
You should tell your doctor if you are taking oral – anticoagulants (medicines which thin the blood).
Povejte svojemu zdravniku, če jemljete peroralne antikoagulate (zdravila za redčenje krvi).
If you take more ARICLAIM than you should
Če ste vzeli večji odmerek zdravila ARICLAIM, kot bi smeli Če vzamete večjo količino zdravila ARICLAIM, kot vam je predpisal vaš zdravnik, nemudoma pokličite svojega zdravnika ali farmacevta.
91 Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
Če ste pozabili vzeti zdravilo ARICLAIM
If you forget to take ARICLAIM Do not take a double dose to make up for a forgotten dose.
88 Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
If your doctor thinks that you no longer need ARICLAIM he will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Če bo vaš zdravnik menil, da zdravila ARICLAIM ne potrebujete več, vam bo naročil, da pred prenehanjem zdravljenja 2 tedna postopoma znižujte svoj odmerek.
Some patients who stop taking ARICLAIM suddenly have had symptoms such as dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo.
Nekateri bolniki, ki so nenadoma prenehali jemati zdravilo ARICLAIM, so imeli simptome, kot so omotica, ščemenje (občutek zbadanja z iglami), motnje spanja (žive sanje, nočne more, nezmožnost spanja), občutek nemira ali razburjenosti, občutek strahu, slabost ali bruhanje, tresenje, glavoboli, občutek razdraženosti, driska, prekomerno znojenje ali vrtoglavica.
Very common side effects (these can affect more than 10 in 100 patients treated) Feeling sick (nausea), somnolence, headache or dizziness.
Zelo pogosti neželeni učinki (se lahko pojavijo pri več kot 1 od 10 zdravljenih bolnikov) Občutek slabosti (navzea), glavobol, suha usta in občutek zaspanosti.
Very common side effects (these can affect more than 1 in 10 patients treated) Feeling sick (nausea), headache, dry mouth, and feeling sleepy.
Pogosti neželeni učinki (se lahko pojavijo pri 1 do 10 bolnikov od 100 zdravljenih bolnikov) • Utrujenost, motnja spanja, tesnoba, občutek razdraženosti ali nenavadne sanje. • Omotica, tresenje ali otrplost, vključno z otrplostjo ali mravljinčasto kožo. • Driska, zaprtje, bruhanje, pekoča zgaga, vetrovi, bolečina v želodcu. • Tinitus (zvonenje v ušesih, kljub temu da ni zunanjega zvoka). • Zamegljen vid. • Občutek bitja srca v prsih, zardevanje, povečano znojenje, nočno znojenje. • Težave z erekcijo, manjša želja po spolnosti. • (Srbeč) izpuščaj. • Mišična bolečina, mišična napetost, mišični krč. • Več zehanja. • Zmanjšanje apetita, zmanjšanje telesne mase.
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Tiredness, trouble sleeping, anxiety, feeling agitated or having abnormal dreams. • Dizziness, tremor or numbness, including numbness or tingling of the skin. • Diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain. • Tinnitus (perception of sound in the ear when there is no external sound). • Blurred eyesight. • Feeling the heart pumping in the chest, flushing, increased sweating, night sweats • Problems getting an erection, less sex drive. • (Itchy) rash. • Muscle pain, muscle tightness, muscle spasm. • Increased yawning. • Lack of appetite, weight loss.
Občasni neželeni učinki (se lahko pojavijo pri 1 do 10 bolnikov od 1. 000 zdravljenih bolnikov) • Vnetje grla. • Zmedenost, zaspanost, pomanjkanje motivacije. • Spremenjeno okušanje stvari, motnja pozornosti, okornost, krči in nehoteni gibi mišic, mišično trzanje, nenormalen način hoje. • Slaba kvaliteta spanja. • Riganje, slaba prebava, gastroenteritis. • Vrtoglavica, ušesna bolečina. • Vnetje jeter, ki lahko povzroči bolečine v trebuhu. • Večje zenice (temni osrednji del očesa), motnja vida. • Hitro ali nepravilno bitje srca. • Težave s spolnostjo, vključno s spremembami v ejakulaciji, orgazmu. • Neobičajna menstruacija, vključno z močno ali podaljšano menstruacijo. • Alergične reakcije, povečano nagnjenje k modricam, mehurji ali občutljivost na sončno svetlobo.
Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling disorientated, feeling sleepy, lack of motivation. • Tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking. • Poor sleep quality • Burping, indigestion, gastroenteritis • Vertigo, ear pain. • Inflammation of the liver that may cause abdominal pain 92 • Large pupils (the dark centre of the eye), visual disturbance. • Fast or irregular heart beat • Sexual problems, including changes in ejaculation, orgasm. • Abnormal periods, including heavy or prolonged periods. • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight • Increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), cold sweats, shivering or fainting. • An increased level of sugar in the blood. • Need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased. • Grinding of teeth, feeling hot/ cold, thirst, throat tightness, nose bleeds. • Weight gain.
89 • Zvišan krvni tlak, občutek mraza v prstih in/ ali prstih na nogah, občutek omotičnosti (zlasti ob prehitrem vstajanju), hladen znoj, drgetanje ali omedlevica. • Zvišan nivo sladkorja v krvi. • Bolj pogosto odvajanje urina, nočno odvajanje urina, težave ali nezmožnost odvajanja urina ali slabši curek urina. • Škrtanje z zobmi, dehidracija, občutek vročine/ mraza, žeja, napeto grlo, krvavitve iz nosu. • Zvečanje telesne mase.
Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated) • Decrease of activity of the thyroid gland. • Dehydration. • Mania (a disorder which symptoms are over activity, racing thoughts and decrease need for sleep). • Bad breath. • Increased pressure in the eye. • Menopausal symptoms. • Contraction of the jaw muscle. • Increased level of cholesterol in the blood, low levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused), syndrome of inadequate secretion of anti-diuretic hormone (SIADH).
Redki neželeni učinki (se lahko pojavijo pri 1 do 10 bolnikov od 10. 000 zdravljenih bolnikov) • Zmanjšana aktivnost žleze ščitnice. • Dehidracija. • Manija (motnja s simptomi prevelike aktivnosti, bežečih misli in zmanjšane potrebe po spanju), agresivnost in jeza. • Slab zadah. • Zvišan tlak v očesu. • Menopavzalni simptomi. • Krčenje čeljustne mišice. • Zvišan nivi holesterola v krvi, nizka raven natrija v krvi (simptomi so slabost in slabo počutje z občutkom šibkosti mišic in zmedenostjo), sindom nezadostnenega izločanja antidiuretičnega hormona (SIADH - syndrome of inadequate secretion of anti- diuretic hormone).
Other possible side effects • Hallucinations, suicidal thoughts, behaviour aggression and anger. • A sensation of restlessness or an inability to sit or stand still or “ Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits. • Passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces). • Having abnormal urine odour. • Chest pain. • Yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin or mucosa (angioedema).
Drugi neželeni učinki • Halucinacije, samomorilne misli, vedenje. • Občutek nemira ali nezmožnosti sedenja ali stanja pri miru ali “ serotoninski sindrom ” (redka reakcija, ki lahko povzroči občutke velike sreče, zaspanost, okornost, nemir, občutek pijanosti, vročino, znojenje ali toge mišice), krči. • Svetlo rdeče krvavo blato pri odvajanju, bruhanje krvi ali črno blato. • Nenormalen vonj urina. • Bolečina v prsnem košu. • Rumeno obarvanje kože (zlatenica), odpoved jeter, Stevens- Johnsonov sindrom, nenadna oteklina mukoze kože (angioedem).
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Vsaka kapsula vsebuje 30 ali 60 mg duloksetina (v obliki klorida).
Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
90 Užitno zeleno črnilo: črni železov oksid - sintetični (E172), rumeni železov oksid - sintetični (E172), propilenglikol, šelak.
What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Vsaka kapsula zdravila ARICLAIM vsebuje pelete duloksetinijevega klorida z oblogo za zaščito pred želodčno kislino.
ARICLAIM is available in two strengths:
Zdravilo ARICLAIM je na voljo v dveh jakostih:
30 and 60 mg.
30 in 60 mg.
The 30 mg capsules has an opaque white body, imprinted with ‘ 30 mg’ and an opaque blue cap, imprinted with ‘ 9543’.
30 mg kapsule imajo neprozorna bela telesa z vtisnjenim napisom ‘ 30 mg ’ in neprozorne modre pokrovčke z vtisnjenim napisom ‘ 9543 ’.
The 60 mg capsules has an opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
60 mg kapsule imajo neprozorna zelena telesa z vtisnjenim napisom ‘ 60 mg ’ in neprozorne modre pokrovčke z vtisnjenim napisom ‘ 9542 ’.
De la Industria, 30,28108 Alcobendas, Madrid, Spain.
Lilly S. A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Španija.
KG Tel: +49 (0) 69 50 50 83 09
KG Tel: +49 (0) 69 50 50 83 09 Eesti Boehringer Ingelheim Pharma GmbH Tel: + 37 2 60 80 940 Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
Tel: +31 30 6 02 59 14 Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00
Tel: +31 30 6 02 59 14 Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00 Österreich Boehringer Ingelheim Austria GmbH Tel: +43 1 710 3739 Polska Boehringer Ingelheim Sp. z o. o.
Tηλ: +30 2 10 89 06 300 Latvija Boehringer Ingelheim Pharma GmbH Tel: +37 167 24 00 68 Lietuva Boehringer Ingelheim Pharma Ges mbH Tel.: +370 37 47 39 22 This leaflet was last approved in
Tηλ: +30 2 10 89 06 300 Latvija Boehringer Ingelheim Pharma GmbH
Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Arixtra vsebuje zdravilno učinkovino natrijev fondaparinuks (1, 5 mg, 2, 5 mg, 5 mg, 7, 5 mg ali 10 mg na brizgo).
Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems caused by blood clots) in patients who are having major surgery to their legs, such as a hip replacement or surgery to repair a knee or hip fracture.
Zdravilo Arixtra (jakosti 1, 5 in 2, 5 mg) se uporablja za preprečevanje venskih tromboemboličnih dogodkov (VTE, zapletov, ki jih povzročajo krvni strdki) pri bolnikih po velikih operativnih posegih na nogah, kot so zamenjava kolka ali operativno zdravljenje kolena ali zloma kolka.
At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat VTEs such as deep vein thrombosis (DVT, a blood clot in the leg) or pulmonary embolism (PE, blood clot in the lung).
Zdravilo Arixtra v večjih jakostih (5, 7, 5 in 10 mg) je mogoče uporabljati za zdravljenje tromboemboličnih dogodkov, kot npr. globoke venske tromboze (DVT, krvni strdek v nogi) ali pljučne embolije (PE, krvni strdek v pljučih).
The 2.5 mg strength is also used to treat patients with unstable angina (a type of chest pain that changes in severity) or who are having a myocardial infarction (heart attack): • without ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) in patients who are not going to undergo urgent angioplasty (within two hours): angioplasty or ‘ percutaneous coronary intervention ’ (PCI) is an operation to unblock the heart ’ s blood vessels, • with ‘ ST segment elevation’ in patients who are receiving thrombolytic medicines (‘ clot busters’) or who are not about to receive any other treatment to restore blood flow to the heart.
Odmerek jakosti 2, 5 mg se uporablja tudi za zdravljenje bolnikov z nestabilno angino pektoris (vrsto bolečine v prsih, katere jakost se naglo spreminja) ali bolnikov, ki imajo miokardni infarkt (srčni napad): • brez „ dviga spojnice ST “ (nenormalen izpis na elektrokardiogramu ali EKG) pri bolnikih, ki ne bodo prestali nujne angioplastike (v okviru dveh ur): angioplastika ali perkutana koronarna intervencija (PCI) je operacija za odpravo blokade srčnih krvnih žil, • z „ dvigom spojnice ST “ pri bolnikih, ki prejemajo trombolitična zdravila („ razkrojevalci strdkov - clot busters “) ali ki niso pred prejemom katerega koli drugega zdravljenja za obnovitev krvnega pretoka v srce.
In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin).
Za preprečevanje tromboemboličnih dogodkov je priporočeni odmerek zdravila Arixtra 2, 5 mg enkrat dnevno, ki se daje s subkutano injekcijo (pod kožo).
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 znižani, 1, 5 mg odmerek.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged discharged from hospital.
Odmerek se lahko prilagodi, odvisno od telesne mase.
Arixtra is not recommended in patients who are about to undergo certain types of PCI.
Zdravila Arixtra se ne priporoča bolnikom, ki so pred določenimi vrstami perkutane koronarne intervencije.
Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting).
Zdravilo Arixtra je anticoagulant: preprečuje koagulacijo (strjevanje) krvi.
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 natrijev fondaparinuks, ki se nahaja v zdravilu Arixtra, blokira eno od snovi (faktorjev), ki sodelujejo pri strjevanju krvi, in sicer faktor Xa.
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 pretok krvi v srce.
The effectiveness of Arixtra has been studied for the prevention of and in the treatment of VTE.
Učinkovitost zdravila Arixtra je bila preučevana z vidika preprečevanja in zdravljenja venskih tromboemboličnih dogodkov.
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 8000 bolnikov) ali z dalteparinom (pri operacijah v trebušni votlini; 2972 bolnikov).
In the treatment of VTE, Arixtra was compared with enoxaparin (DVT:
Pri zdravljenju venskih tromboemboličnih dogodkov so zdravilo Arixtra primerjali z enoksaparinom (globoka vensko tromboza:
2,192 patients) or with unfractionated heparin (PE:
2192 bolnikov) ali z nefrakcioniranim heparinom (pljučna embolija:
2,184 patients).
2184 bolnikov).
The first compared the effects of Arixtra with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Arixtra with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
V drugi študiji pa so primerjali učinke zdravila Arixtra s standardnim zdravljenjem (nefrakcioniranim heparinom pri ustreznih bolnikih ali s placebom) pri več kot 12. 000 bolnikih s miokardnim infarktom z dvigom spojnice ST.
The main measure of effectiveness was the proportion of patients who died or had an ‘ ischaemic event’ (restriction of blood supply to an organ, including the heart).
Glavno merilo učinkovitosti je bil delež bolnikov, ki so umrli ali so imeli „ ishemični dogodek “ (omejitev dotoka krvi do organov, vključno do srca).
What benefit has Arixtra shown during the studies?
Kakšne koristi je zdravilo Humira izkazalo med raziskavami?
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 približno 5% bolnikov v vsaki skupini umrlo ali imelo ishemični dogodek po devetih dneh.
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 zmanjšalo tvaganje smrti ali ponovnega srčnega napada za 14% po 30 dneh.
As with other antithrombotic medicines, the most common side effect of Arixtra is bleeding.
Vendar ti rezultati niso bili zadostni, da bi pokazali, da je zdravilo Arixtra bilo bolj učinkovito kot nefrakcionirani heparin.
Why has Arixtra been approved?
Kakšna tveganja so povezana z zdravilom Arixtra?
The Committee for Medicinal Products for Human Use (CHMP) decided that Arixtra’ s benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Kot pri vseh drugih antitrombotičnih zdravilih je najpogostejši neželeni učinek zdravila Arixtra krvavenje.
The Committee recommended that Arixtra be given marketing authorisation.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Arixtra, glejte Navodilo za uporabo.