FrancophonIA/ELRC3.0 huggingface dataset:
English: There was a significantly (p<0.05) greater incidence of cardiovascular/thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis and pulmonary embolism) detected in the parecoxib/valdecoxib treatment group compared to the placebo/placebo treatment group for the IV dosing period (2.2% and 0.0% respectively) and over the entire study period (4.8% and 1.3% respectively).
Slovenian: Pomembno večjo pojavnost (p < 0,05) kardiovaskularnih/trombemboličnih dogodkov (miokardni infarkt, ishemijo, cerebrovaskularni insult, globoko vensko trombozo in pljučno embolijo) so odkrili pri skupini, zdravljeni s parekoksibom/valdekoksibom, v primerjavi s skupino, ki je v obdobju i.v.
English: This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Slovenian: Zdravilo Dynastat vsebuje natrij To zdravilo vsebuje manj kot 23 mg natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: IV line solution compatibility
Slovenian: Kompatibilnost v intravenski poti
English: The only other acceptable solvents for reconstitution are:
Slovenian: Kot drugi vehikel za pripravo raztopine so dovoljeni samo:
English: or muscle tissue.
Slovenian: • obarvanje kože ali modrice
English: Renal failure acute
Slovenian: Akutna ledvična odpoved
English: In addition to routine adverse event reporting, pre-specified event categories, adjudicated by an independent expert committee, were examined in two placebo-controlled safety studies in which patients received parecoxib for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days.
Slovenian: Poleg rutinskega poročanja neželenih dogodkov so v dveh s placebom nadzorovanih študijah varnosti raziskali vnaprej opredeljene kategorije pojavov, ki jih je presojal odbor neodvisnih strokovnjakov.
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
English: BUN increased.
Slovenian: • povečano znojenje
English: Powder vial: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
Slovenian: Viala s praškom: Ena viala vsebuje 40 mg parekoksiba (v obliki 42,36 mg natrijevega parekoksibata).
English: Upper gastrointestinal (GI) complications (perforations, ulcers or bleedings [PUBs]), some of them resulting in fatal outcome, have occurred in patients treated with parecoxib.
Slovenian: Pri bolnikih, zdravljenih s parekoksibom, so se pojavili zapleti v zgornjih prebavilih (perforacije, ulkusi ali krvavitve), ki so imeli v nekaterih primerih smrten izid.
English: Disodium hydrogen phosphate Phosphoric acid and/or sodium hydroxide (for pH adjustment).
Slovenian: Prašek natrijev hidrogenfosfat fosforjeva kislina in/ali natrijev hidroksid (za uravnavanje pH).
English: How to store Dynastat
Slovenian: Shranjevanje zdravila Dynastat
English: - if you have had a serious allergic reaction (especially a serious skin reaction) to any medicines - if you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections) - if you currently have a gastric or intestinal ulcer or bleeding in the stomach or gut - if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e.g.
Slovenian: • če ste imeli alergijsko reakcijo na skupino zdravil, imenovano “sulfonamidi” (npr. nekateri antibiotiki za zdravljenje okužb)
English: Caution should be used when initiating treatment with Dynastat in patients with dehydration.
Slovenian: Pri dehidriranih bolnikih je med uvajanjem zdravljenja z zdravilom Dynastat potrebna previdnost.
English: Injection into an IV line delivering glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in section 6.6, is not recommended as this may cause precipitation from solution.
Slovenian: Injiciranje v intravensko pot, po kateri teče 50 mg/ml (5 %) glukoza v raztopini Ringerjevega laktata ali kakšna druga intravenska tekočina, ki ni navedena v poglavju 6.6, ni priporočljivo, ker lahko povzroči precipitacijo natrijevega parekoksiba iz raztopine.
English: Dyspnoea
Slovenian: Dispneja
English: Abnormal sternal serous wound drainage, wound infection Blood and lymphatic system disorders Anaemia postoperative
Slovenian: Bolezni krvi in limfatičnega sistema Pooperacijska anemija
English: Withdraw with a sterile needle and syringe, 2 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the parecoxib 40 mg vial.
Slovenian: S sterilno iglo in brizgo izvlecite 2 ml dovoljenega vehikla; zabodite iglo skozi osrednji del gumijastega zamaška in prenesite vehikel v 40 mg vialo.
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal antiinflammatory drugs (NSAIDs) including COX-2 inhibitors.
Slovenian: Bolniki, ki so po uporabi acetilsalicilne kisline ali nesteroidnih protivnetnih zdravil (NSAIDnonsteroidal anti-inflammatory drugs), vključno z zaviralci COX-2, doživeli bronhospazem, akutni rinitis, nosne polipe, angionevrotičen edem, urtikarijo ali druge alergijske reakcije.
English: Each vial contains 40 mg parecoxib, as 42.36 mg parecoxib sodium.
Slovenian: Ena viala vsebuje 40 mg parekoksiba, kar ustreza 42,36 mg natrijevega parekoksibata.
English: Caution should be exercised with respect to monitoring the incision for signs of infection in surgical patients receiving Dynastat.
Slovenian: Kirurškim bolnikom, zdravljenim z zdravilom Dynastat, je treba iz previdnosti nadzirati operacijsko rano glede prisotnosti znakov okužbe.
English: Thus, each 2 ml of reconstituted solution contains 40 mg of parecoxib.
Slovenian: Tako 2 ml rekonstituirane raztopine vsebuje 40 mg parekoksiba.
English: Dynastat should be introduced with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and the maximum daily dose should be reduced to 40 mg.
Slovenian: Pri bolnikih z zmerno okvaro jeter (ocena od 7 do 9 po Child-Pughu) pa je treba zdravljenje začeti previdno in s polovičnim običajnim priporočenim odmerkom zdravila Dynastat; maksimalni dnevni odmerek je treba zmanjšati na 40 mg.
English: Administration is by intramuscular (IM) or intravenous (IV) injection.
Slovenian: Zdravilo se aplicira kot intramuskularna (i.m.)
English: The magnitude of analgesic effect of the 40 mg dose was comparable with that of ketorolac 60 mg IM or ketorolac 30 mg IV. After a single dose, the duration of analgesia was dose and clinical pain model dependent, and ranged from 6 to greater than 12 hours.
Slovenian: Izrazitost analgetičnega učinka 40 mg odmerka je bila primerljiva tisti po 60 mg ketorolaka intramuskularno ali 30 mg ketorolaka intravensko.
English: • sodium chloride 9 mg/ml (0.9%) solution for injection/infusion
Slovenian: • 9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje/infundiranje
English: Cardiovascular
Slovenian: Trombocitopenija
English: Renal function should be monitored when parecoxib and any of these medicinal products are coadministered.
Slovenian: Med sočasno uporabo parekoksiba s katerim od teh zdravil je treba nadzirati delovanje ledvic.
English: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium).
Slovenian: Ena viala vsebuje 40 mg parekoksiba (v obliki 42,36 mg natrijevega parekoksibata).
English: Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib).
Slovenian: Za rekonstitucijo liofiliziranega parekoksiba (v obliki parekoksiba) uporabite aseptično tehniko.
English: Patients were randomized within 24-hours post-CABG surgery to: parecoxib initial dose of 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=544) for the remainder of a 10 day treatment period; placebo IV followed by valdecoxib PO (n=544); or placebo IV followed by placebo PO (n=548).
Slovenian: na 12 ur najmanj 3 dni, nato pa preostalih 10 dni zdravljenja še valdekoksib peroralno (20 mg na 12 ur) (n = 544); po prejemanju placeba i.v.
English: The IM injection is to be given slowly and deeply into the muscle and the IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
Slovenian: Intravensko bolusno injekcijo se lahko daje hitro in neposredno v veno ali v obstoječo intravensko pot.
English: • sodium chloride 9 mg/ml (0.9%) solution for injection/infusion;
Slovenian: • 9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje/infundiranje;
English: Lithium serum concentration should be monitored closely when initiating or changing parecoxib therapy in patients receiving lithium.
Slovenian: Če uvedemo ali spremenimo zdravljenje s parekoksibom pri bolnikih, ki dobivajo litij, je treba koncentracijo litija v serumu natančno nadzorovati.
English: Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: Vehikli za rekonstitucijo Za pripravo raztopine 40 mg zdravila Dynastat uporabite 2 ml raztopine natrijevega klorida 9 mg/ml
English: Injection into an IV line delivering glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed above, is not recommended as this may cause precipitation from solution.
Slovenian: Injiciranje v intravensko pot, po kateri teče 50 mg/ml (5 %) glukoza v raztopini Ringerjevega laktata za injiciranje ali kakšna druga intravenska tekočina, ki ni navedena v tem poglavju, ni priporočljivo, ker lahko povzroči precipitacijo iz raztopine.
English: Acetylsalicyclic acid and other NSAIDs
Slovenian: • acetilsalicilno kislino (aspirin) ali druga protivnetna zdravila
English: Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines - if you are more than 6 months pregnant - if you are breast-feeding - if you have severe liver disease - if you have inflammation of the intestines (ulcerative colitis or Crohn's disease) - if you have heart failure - if you are about to have heart surgery or surgery on your arteries (including any coronary artery procedure)
Slovenian: Taka reakcija lahko vključuje piskajoče dihanje (bronhospazem), zelo zamašen nos, srbenje kože, izpuščaj ali otekanje obraza, ustnic ali jezika, druge alergijske reakcije ali nosne polipe po jemanju teh zdravil
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Dynastat in vsebina pakiranja
English: Ecchymosis, rash, urticaria
Slovenian: Ekhimoze, izpuščaj, urtikarija
English: ▪ Dry socket (inflammation and pain after a tooth extraction) ▪ Increased sweating ▪ Low levels of potassium in blood test results
Slovenian: • sindrom suhe jamice (vnetje in bolečina po izdrtju zoba)
English: Some people may be given lower doses: ▪ People with liver problems ▪ People with severe kidney problems ▪ Patients over 65 who weigh less than 50 kg ▪ People taking fluconazole.
Slovenian: • bolniki, starejši od 65 let, ki tehtajo manj kot 50 kg
English: - if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages - if you have or have had problems with your blood circulation (peripheral arterial disease)
Slovenian: možgansko kap, lažjo obliko možganske kapi (tranzitorna ishemična ataka - TIA), ali zamašitev krvnih žil, ki vodijo do srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela
English: Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment.
Slovenian: Pri zdravljenju s parekoksibom/valdekoksibom so opazili več zapletov v zvezi s kirurškimi ranami (največkrat v zvezi z rano prsnice).
English: It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors).
Slovenian: Gre za zdravilo iz skupine t. i. zaviralcev COX-2 (to je okrajšava za "zaviralci ciklooksigenaze-2").Bolečino in otekanje v telesu včasih povzročijo posebne snovi, ki se imenujejo prostaglandini.
English: OUTER CARTON: 40 mg powder and solvent for solution for injection
Slovenian: ZUNANJA ŠKATLA: 40 mg prašek in vehikel za raztopino za injiciranje
English: Cases of severe hypotension shortly following parecoxib administration have been reported in postmarketing experience with parecoxib.
Slovenian: V obdobju po začetku trženja zdravila so poročali o primerih hude hipotenzije, ki se je pojavila kmalu po aplikaciji parekoksiba.
English: ▪ Acetylsalicylic acid (aspirin) or other anti-inflammatory medicines ▪ Fluconazole - used for fungal infections ▪ ACE inhibitors, Angiotensin-II inhibitors, beta blockers and diuretics - used for high blood pressure and heart conditions ▪ Ciclosporin or Tacrolimus - used after transplants ▪ Warfarin - or other warfarin like medicines used to prevent blood clots including newer medicines like apixaban, dabigatran, and rivaroxaban
Slovenian: • zaviralce ACE, antagoniste angiotenzina II, antagoniste adrenergičnih receptorjev beta in diuretike - uporabljajo se pri visokem krvnem tlaku in boleznih srca
English: • glucose 50 mg/ml (5%) solution for infusion
Slovenian: • 50 mg/ml (5 %) raztopina glukoze za infundiranje
English: In a large (N=1050) major orthopedic/general surgery trial, patients received an initial dose of parecoxib 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=525) for the remainder of a 10 day treatment period, or placebo IV followed by placebo PO (n=525).
Slovenian: na 12 ur, nato pa valdekoksib peroralno (20 mg na 12 ur) (n = 525) preostalih 10 dni obdobja zdravljenja ali pa so po prejemanju placeba i.v.
English: • glucose 50 mg/ml (5%) solution for infusion;
Slovenian: • 50 mg/ml (5%) raztopina glukoze za infundiranje;
English: Dynastat 40 mg powder for solution for injection
Slovenian: Dynastat 40 mg prašek za raztopino za injiciranje
English: Administration other than IV or IM
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN
English: ▪ Lithium - used to treat depression ▪ Rifampicin - used for bacterial infections ▪ Antiarrhythmics - used to treat an irregular heartbeat ▪ Phenytoin or Carbamazepine - used for epilepsy ▪ Methotrexate - used for rheumatoid arthritis and cancer ▪ Diazepam - used for sedation and anxiety ▪ Omeprazole - used for treating ulcers
Slovenian: • diazepam - uporablja se za pomiritev in pri tesnobi • omeprazol - uporablja se za zdravljenje razjed
English: Dosing.
Slovenian: Dojenje
English: Dynastat 40 mg powder for injection Parecoxib
Slovenian: Dynastat 40 mg prašek za raztopino za injiciranje parekoksib
English: Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Zdravilo Dynastat je treba pregledati in se tako prepričati, da ne vsebuje delcev in ni obarvan.
English: No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Slovenian: Bolnikom z blago okvaro jeter (ocena od 5 do 6 po Child-Pughu) odmerka praviloma ni treba prilagajati.
English: ▪ If you are dehydrated - this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids ▪ If you have an infection as it may hide a fever (which is a sign of infection) ▪ If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban, dabigatran, and rivaroxaban) ▪ If you use medicines called corticosteroids (e.g. prednisone) ▪ If you use a class of medicines used to treat depression called selective serotonin re-uptake inhibitors (e.g. sertraline)
Slovenian: • če jemljete zdravila proti strjevanju krvi (npr. varfarin/varfarinu podobne antikoagulante ali novejše peroralne antikoagulante, npr. apiksaban, dabigatran in rivaroksaban)
English: • sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion.
Slovenian: • 4,5 mg/ml (0,45 %) raztopina natrijevega klorida in 50 mg/ml (5 %) raztopina glukoze za injiciranje/infundiranje.
English: • sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion; or
Slovenian: • 4,5 mg/ml (0,45 %) raztopina natrijevega klorida in 50 mg/ml (5 %) raztopina glukoze za injiciranje/infundiranje; ali
English: • glucose 50 mg/ml (5%) solution for infusion; or
Slovenian: • 5 % (50 mg/ml) raztopino glukoze za infundiranje; ali
English: Uncommon: may affect up to 1 in 100 people ▪ Heart attack ▪ There is a risk of cerebrovascular disease e.g. stroke, or transient ischaemic attack (transient reduced blood flow to the brain)/mini-stroke or angina, or blockages to blood vessels to the heart or brain ▪ Blood clot in the lungs ▪ Worsening of high blood pressure ▪ Ulcers in the digestive system, chronic stomach acid reflux ▪ The heart may beat more slowly
Slovenian: (prehodno zmanjšan pretok krvi v možgane)/mini možganska kap ali angina pektoris ali ovira do krvnih žil, srca ali možganov
English: wheezing, difficulty breathing or swallowing (potentially fatal) ▪ Swelling, blistering or peeling of the skin ▪ Acute kidney failure ▪ Hepatitis (inflamed liver) ▪ Inflammation of the gullet (oesophagus) ▪ Inflammation of the pancreas (can lead to stomach pain)
Slovenian: izpuščaj na koži, otekanje obraza, ustnic ali jezika, ki lahko povzroči piskajoče ali težko dihanje ali požiranje - to se pojavi redko
English: • sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion
Slovenian: • 0,45 % (4,5 mg/ml) raztopino natrijevega klorida in 5 % (50 mg/ml) raztopino glukoze za injiciranje/infundiranje
English: Renal failure,
Slovenian: Ledvična okvara
English: Dynastat 40 mg powder and solvent for solution for injection
Slovenian: Dynastat 40 mg prašek in vehikel za raztopino za injiciranje
English: Dynastat 40 mg powder and solvent for solution for injection parecoxib
Slovenian: Dynastat 40 mg prašek in vehikel za raztopino za injiciranje parekoksib
English: MA (EU) Number Invented name Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
English: 2 vials +2 pre-filled syringes +2 plunger rods + 2 vial adapters + 2 needles
Slovenian: 2 viali + 2 napolnjeni injekcijski brizgi + 2 bata brizge + 2 adapterja viale + 2 igli
English: 3 x (1 vial + 1 prefilled syringe + 1 plunger rod + 1 vial adapter + 1 needle) (multipack)
Slovenian: 3 x (1 viala + 1 napolnjena injekcijska brizga + 1 bat brizge + 1 adapter viale + 1 igla) (skupno pakiranje)
English: 1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 needle
Slovenian: 1 viala + 1 napolnjena injekcijska brizga + 1 bat brizge + 1 adapter viale + 1 igla
English: The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Slovenian: Največji dovoljeni odmerek je ena tableta najvišje jakosti (80/10 mg) enkrat na dan.
English: Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s.
Slovenian: Obe sta učinkovini za zniževanje krvnega tlaka, ki sta v Evropski uniji (EU) na voljo od devetdesetih let prejšnjega stoletja.
English: Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.
Slovenian: Ker se telmisartan in amlodipin uporabljata že vrsto let, je družba predstavila informacije iz znanstvene literature, pa tudi rezultate novih študij, ki jih je izvedla.
English: The European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Twynsta, veljavno po vsej Evropski uniji, izdala 7. oktobra 2010.
English: It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).
Slovenian: Na voljo je v obliki tablet (40 mg telmisartana/10 mg amlodipina; 40 mg telmisartana/5 mg amlodipina; 80 mg telmisartana/10 mg amlodipina; 80 mg telmisartana/5 mg amlodipina).
English: Other information about Twynsta:
Slovenian: Druge informacije o zdravilu Twynsta:
English: Twynsta telmisartan / amlodipine
Slovenian: Twynsta telmisartan/amlodipin
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Slovenian: Povzroči zaporo posebnih kanalčkov na površini celic, imenovanih kalcijevi kanalčki, skozi katere v celico običajno vstopajo kalcijevi ioni.
English: This is a summary of the European public assessment report (EPAR) for Twynsta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Twynsta.
English: The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.
Slovenian: Glavno merilo učinkovitosti v vseh treh študijah je bilo znižanje diastoličnega krvnega tlaka (krvnega tlaka, izmerjenega med dvema udarcema srca) po osmih tednih.
English: The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Twynsta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The full EPAR for Twynsta can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Twynsta je na voljo na spletni strani agencije under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Twynsta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Telmisartan je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Slovenian: Zdravilo Twynsta se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih (starejših od 18 let).
English: 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 Twynsta.
Slovenian: 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.
English: What benefit has Twynsta shown during the studies?
Slovenian: Kakšne koristi je zdravilo Twynsta izkazalo med študijami?
English: The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Slovenian: Najpogostejša neželena učinka zdravila Twynsta (opažena pri več kot 1 bolniku od 10) sta omotica in periferni edem (otekanje, zlasti gležnjev in stopal).