FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio vs. warfarin; CI = Confidence Interval; N = number of subjects in safety population; n = number of events; CRNM = clinically relevant non-major a On-Treatment Period: Time from first dose of study drug to last dose plus 3 days.
Slovenian: Okrajšave: ICH = intrakranialna krvavitev, HR = razmerje tveganja proti varfarinu; CI = interval zaupanja; N = število preiskovancev v populaciji za proučevanje varnosti; n = število dogodkov; CRNM = klinično pomembna krvavitev, ki ni bila velika.
English: ≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1
Slovenian: ≥ 30 do ≤ 50 1302 9 > 50 do ≤ 70 2093 8 > 70 do ≤ 90 1661 10 > 90 do ≤ 110 927 2 > 110 do ≤ 130 497 1
English: Ciclosporin, dronedarone, erythromycin, ketoconazole
Slovenian: heparin, klopidogrel aliantagoniste vitamina K, n.pr.
English: EU/1/15/993/002 10 film-coated tablets
Slovenian: EU/1/15/993/00210 filmsko obloženih tablet
English: Lixiana film-coated tablets edoxaban
Slovenian: Zdravilo Lixiana filmsko-obložene tablete edoksaban
English: EU/1/15/993/024 98 film-coated tablets
Slovenian: EU/1/15/993/02498 filmsko obloženih tablet
English: Changing from Lixiana to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban)
Slovenian: Prehod z zdravila Lixiana na peroralne antikoagulante, ki niso antagonisti vitamina K (dabigatran, rivaroksabanali apiksaban)
English: EU/1/15/993/003 10 film-coated tablets
Slovenian: EU/1/15/993/00310 filmsko obloženih tablet
English: The recommended dose is 60 mg edoxaban once daily.
Slovenian: Preprečevanje možganske kapi in sistemske embolije Priporočeni odmerek je 60 mg edoksabanaenkrat na dan.
English: Stop taking the vitamin K antagonist (e.g. warfarin).
Slovenian: varfarina)na zdravilo Lixiana Prenehajte jemati antagonist vitamina K (n.pr.
English: Stop taking the anticoagulant (e.g. heparin) and start Lixiana at the time of the next scheduled anticoagulant dose.
Slovenian: heparin) in začnite jemati zdravilo Lixiana ob času naslednjega načrtovanega odmerka antikoagulanta.
English: EU/1/15/993/011 98 film-coated tablets
Slovenian: EU/1/15/993/01198 filmsko obloženih tablet
English: Or scan the QR code with your smartphone:
Slovenian: www.dspatient.eu ali s pametnim telefonom skenirajte spodnjo kodo QR: Koda QR bo dodana naknadno.
English: Anticoagulants: Co-administration of edoxaban with other anticoagulants is contraindicated due to increased risk of bleeding (see section 4.3).
Slovenian: Antikoagulanti, antitrombocitna sredstva, nesteroidna protivnetna zdravila (NSAID) ter selektivni zaviralci privzema serotonina (SSRI)/zaviralci privzema serotonina in noradrenalina (SNRI) Antikoagulanti: sočasna uporaba edoksabana z drugimi antikoagulanti je kontraindicirana zaradi zvečane nevarnosti krvavitve (glejte poglavje 4.3).
English: Discontinue Lixiana and start the parenteral anticoagulant at the time of the next scheduled dose of Lixiana.
Slovenian: Teh zdravil ne smete uporabljati sočasno.Ukinite zdravilo Lixiana in začnite s parenteralnim antikoagulantom ob času naslednjega načrtovanega odmerka zdravila Lixiana.
English: EU/1/15/993/021 60 film-coated tablets
Slovenian: EU/1/15/993/02160 filmsko obloženih tablet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg edoxaban (as tosilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 60 mg edoksabana (v obliki edoksabanijevega tozilata).
English: EU/1/15/993/022 84 film-coated tablets
Slovenian: EU/1/15/993/02284 filmsko obloženih tablet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg edoxaban (as tosilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 30 mg edoksabana (v obliki edoksabanijevega tozilata).
English: • Bleeding from the vagina
Slovenian: • krvavitev iz nožnice,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg edoxaban (as tosilate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje15 mg edoksabana (v obliki edoksabanijevega tozilata).
English: It was to be available as tablets (75 mg).
Slovenian: Na voljo naj bi bilo v tabletah (75 mg).
English: This reduces the risk of a blood clot forming and helps prevent another heart attack or stroke.
Slovenian: To zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečevanju novega srčnega napada ali kapi.
English: Ref. EMEA/254399/2009
Slovenian: : EMEA/410298/2009 Error!
English: The application was at day 177 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 177. dan postopka.
English: Questions and answers on the withdrawal of the marketing authorisation application for Clopidogrel Teva Pharma clopidogrel
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Clopidogrel Teva Pharma klopidogrel
English: When the blood clots, this is due to special cells in the blood called platelets sticking together (aggregating).
Slovenian: Kri se strjuje zaradi posebnih celic v krvi, imenovanih trombociti, ki se zlepljajo (agregirajo) med seboj.
English: It was to be used in patients who had recently had a myocardial infarction (heart attack) or an ischaemic stroke (non-bleeding stroke), or in patients with peripheral arterial disease (problems with blood flow in the arteries).
Slovenian: Uporabljalo naj bi se pri bolnikih, ki so pred kratkih doživeli miokardni infarkt (srčni napad) ali ishemično kap (kap zaradi žilne zapore), ali pri bolnikih s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah).
English: Because Clopidogrel Teva Pharma was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Slovenian: Ker je bilo zdravilo Clopidogrel Teva Pharma razvito kot generično zdravilo, je družba predložila rezultate študij, ki so bile opravljene za proučitev, ali je zdravilo biološko enakovredno referenčnemu zdravilu.
English: Clopidogrel Teva Pharma was expected to be used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel Teva Pharma naj bi se uporabljalo pri odraslih bolnikih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdevanje krvnih žil).
English: This means that Clopidogrel Teva Pharma was intended to be similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je zdravilo Clopidogrel Teva Pharma podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Clopidogrel Teva Pharma could not have been approved for the prevention of atherothrombotic events in patients who have had myocardial infarction, ischaemic stroke or who have established peripheral arterial disease.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika vloge izrazil nekatere zadržke in začasno menil, da se zdravilo Clopidogrel Teva Pharma ne more odobriti za preprečevanje aterotrombotičnih dogodkov pri bolnikih z miokardnim infarktom, ishemično kapjo ali potrjeno periferno arterijsko boleznijo.
English: This stops the platelets becoming ‘sticky'.
Slovenian: To preprečuje, da bi trombociti postali lepljivi.
English: On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.
Slovenian: je dne 22. aprila 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Clopidogrel Teva Pharma, namenjenim preprečevanju aterotrombotičnih dogodkov pri bolnikih z miokardnim infarktom, ishemično kapjo ali potrjeno periferno arterijsko boleznijo.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Slovenian: pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
English: The CHMP concluded that the studies presented did not provide enough evidence to show that Clopidogrel Teva Pharma was bioequivalent to the reference medicine Plavix.
Slovenian: CHMP je zaključil, da predložene študije niso zadosten dokaz, da je zdravilo Clopidogrel Teva Pharma biološko enakovredno referenčnemu zdravilu Plavix.
English: The active substance in Clopidogrel Teva Pharma and in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel Teva Pharma in Plavix, klopidogrel, je zaviralec agregacije trombocitov.
English: Clopidogrel Teva Pharma was developed as a ‘generic medicine'.
Slovenian: Zdravilo Clopidogrel Teva Pharma je bilo razvito kot generično zdravilo.
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel Teva Pharma je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: What is Clopidogrel Teva Pharma?
Slovenian: Kaj je zdravilo Clopidogrel Teva Pharma?
English: Clopidogrel Teva Pharma is expected to work in the same way as the reference medicine, Plavix.
Slovenian: Zdravilo Clopidogrel Teva Pharma naj bi delovalo enako kot referenčno zdravilo Plavix.
English: At this point in time, the CHMP was of the opinion that Clopidogrel Teva Pharma could not be considered a generic medicine of Plavix, the reference medicinal product.
Slovenian: Takrat je CHMP menil, da zdravilo Clopidogrel Teva Pharma ne more veljati kot zdravilo, ki je biološko podobno referenčnemu zdravilu Plavix.
English: How is Clopidogrel Teva Pharma expected to work?
Slovenian: Kako naj bi zdravilo Clopidogrel Teva Pharma delovalo?
English: What was Clopidogrel Teva Pharma expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Clopidogrel Teva Pharma uporabljalo?
English: This overview was last updated in 10-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2018.
English: Additional data from an extension of this study in children aged 13 to 18 years confirmed the initial results.
Slovenian: Dodatni podatki iz razžiritve te študije, ki je vključevala otroke, stare od 13 do 18 let, so potrdili prvotne rezultate.
English: The effectiveness of Strensiq was also generally supported by several additional small studies.
Slovenian: Učinkovitost zdravila Strensiq je na splošno podprlo več dodatnih majhnih študij.
English: The study also looked at other measures of effectiveness such as growth in height.
Slovenian: V študiji so proučevali tudi druga merila učinkovitosti, kot je telesna rast.
English: Strensiq (asfotase alfa)
Slovenian: Strensiq (asfotaza alfa)
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu308594.
Slovenian: Nadaljnje informacijeglede določitve zdravila sirote lahko najdete tukaj: https://www.ema.europa.eu/medicines/human/orphan-designations/eu308594.
English: What measures are being taken to ensure the safe and effective use of Strensiq?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Strensiq?
English: The Agency noted that hypophosphatasia is a serious and life-threatening disease for which no treatment is authorised.
Slovenian: Agencija je upoštevala, da je hipofosfatazija resna in smrtno nevarna bolezen, za katero ni odobreno nobeno zdravljenje.
English: Further information on Strensiq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Strensiq
Slovenian: Več informacij o zdravilu Strensiq je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Strensiq
English: Given that hypophosphatasia is an extremely rare disease, data in this population will likely remain limited.
Slovenian: Ker je hipofosfatazija izjemno redka bolezen, bodo podatki pri tej skupini bolnikov verjetno ostali omejeni.
English: Although the main study was small and did not directly compare Strensiq with another treatment or with untreated patients, the Agency considered that the improvement seen in the bones and the apparent growth was relevant.
Slovenian: Čeprav je bila glavna študija majhna in z njo niso neposredno primerjali zdravila Strensiq z drugo obliko zdravljenja ali nezdravljenimi bolniki, je agencija menila, da je bilo izboljšanje, ki so ga opazili pri kosteh in pridobivanju telesne višine, pomembno.
English: Strensiq has been studied in one main study in 13 children between 6 and 12 years of age.
Slovenian: Zdravilo Strensiq so proučevali v eni glavni študiji, ki je vključevala 13 otrok, starih od 6 do 12 let.
English: The European Medicines Agency decided that Strensiq's benefits are greater than its risks and it be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Strensiq večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As the amount given depends on the patient's bodyweight, the doctor will need to adjust the dose as the patient's weight changes, particularly in growing children.
Slovenian: Ker je uporabljena količina odvisna od telesne mase bolnika, bo zdravnik moral odmerek prilagoditi, ko se bo spremenila bolnikova telesna masa, predvsem pri rastočih otrocih.
English: The enzyme ‘tissue non-specific alkaline phosphatase' (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body.
Slovenian: Encim „za tkivo nespecifična alkalna fosfataza“ (ALP) ima ključno vlogo pri ustvarjanju in ohranjanju zdravih kosti, saj uravnava kalcij in fosfate v telesu.
English: An overview of Strensiq and why it is authorised in the EU
Slovenian: Pregled zdravila Strensiq in zakaj je odobreno v EU
English: Patients with hypophosphatasia cannot make enough working ALP, which leads to weak bones.
Slovenian: Bolniki s hipofosfatazijo ne morejo proizvesti dovolj delujoče ALP, kar povzroča šibke kosti.
English: What is Strensiq and what is it used for?
Slovenian: Kaj je zdravilo Strensiq in za kaj se uporablja?
English: The most common side effects with Strensiq (which may affect more than 1 in 10 people) are headache, erythema (reddening of the skin), pain in arms and legs, fever, irritability, injection site reactions (such as pain, rash and itching) and contusion (bruising).
Slovenian: Najpogostejši neželeni učinki zdravila Strensiq (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, eritem (pordela koža), bolečina v rokah in nogah, povišana telesna temperatura, razdražljivost, reakcije na mestu injiciranja (kot so bolečina, izpuščaj in srbenje) in kontuzija (podplutba).
English: Strensiq received a marketing authorisation valid throughout the EU on 28 August 2015.
Slovenian: Za zdravilo Strensiq je bilo 28. avgusta 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: Strensiq has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Strensiq je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: In the historical controls, most children did not experience similar improvements in their joints or gain in height over a comparable period of time.
Slovenian: Pretekli kontrolni podatki so pokazali, da večina otrok ni imela podobnih izboljšanj v sklepih ali pridobivanju telesne višine v primerljivem časovnem obdobju.
English: As for all medicines, data on the use of Strensiq is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Strensiq stalno spremljajo.
English: The main measure of effectiveness of the medicine was the improvement in x-ray appearance of the wrists and knee joints before and after treatment with Strensiq.
Slovenian: Glavno merilo učinkovitosti zdravila je bilo izboljšanje rentgenskega videza zapestnih in kolenskih sklepov pred zdravljenjem z zdravilom Strensiq in po njem.
English: Regarding safety, injection site reactions and other side effects were considered manageable with the recommendations in place.
Slovenian: Z varnostnega vidika so bili reakcije na mestu injiciranja in drugi neželeni učinki obvladljivi ob upoštevanju obstoječih priporočil.
English: It is given by injection under the skin either six times a week (in a dose of 1 mg per kilogram bodyweight) or three times a week (in a dose of 2 mg/kg).
Slovenian: Daje se z injiciranjem pod kožo šestkrat na teden (v odmerku 1 mg na kilogram telesne mase) ali trikrat na teden (v odmerku 2 mg/kg).
English: Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Slovenian: Hipofosfatazija je redka dedna bolezen kosti, ki lahko povzroči zgodnjo izgubo zob, nepravilno oblikovane kosti, pogoste zlome kosti in težave z dihanjem.
English: Side effects reported with Strensiq are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Strensiq, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood.
Slovenian: Strensiq je zdravilo, ki se uporablja za dolgotrajno zdravljenje bolnikov s hipofosfatazijo, ki se je pojavila v otroštvu.
English: X-rays of children given Strensiq were also compared with similar x-rays available from 16 children who had not received Strensiq (‘historical controls').
Slovenian: Rentgenske slike otrok, ki so prejemali zdravilo Strensiq, so primerjali s podobnimi rentgenskimi slikami 16 otrok, ki niso prejeli zdravila Strensiq („pretekli kontrolni podatki“).
English: Asfotase alfa, the active substance in Strensiq, is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.
Slovenian: Asfotaza alfa, učinkovina v zdravilu Strensiq, je različica humanega encima ALP in deluje kot nadomestek, kar poviša ravni delujoče ALP.
English: What benefits of Strensiq have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Strensiq izkazalo v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Strensiq have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Strensiq upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Since Strensiq has been authorised under exceptional circumstances, the company that markets Strensiq will set up a registry of patients with hypophosphatasia to collect information on the disease and on the long-term safety and effectiveness of Strensiq.
Slovenian: Ker je zdravilo Strensiq pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, vzpostavilo register bolnikov s hipofosfatazijo, s pomočjo katerega bo zbiralo podatke o bolezni in dolgotrajni varnosti ter učinkovitosti zdravila Strensiq.
English: For more information about using Strensiq, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Strensiq glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The company that markets Strensiq will provide patients and carers with educational materials to ensure that the medicine is used correctly and to minimise the risk of medication errors.
Slovenian: Podjetje, ki trži zdravilo Strensiq, bo za bolnike in negovalce pripravilo izobraževalno gradivo, ki bo zagotavljalo, da se zdravilo uporablja pravilno, in zmanjšalo tveganje za napake pri uporabi zdravila.
English: Patients were given either 2 mg/kg or 3 mg/kg Strensiq three times a week for 24 weeks.
Slovenian: Bolniki so prejemali zdravilo Strensiq v odmerku 2 mg/kg ali 3 mg/kg trikrat na teden v obdobju 24 tednov.
English: Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 December 2008.
Slovenian: Bolezen hipofosfatazija je redka, zato je bilo zdravilo Strensiq 3. decembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: This study showed that children given Strensiq had an improvement in their joint structure as demonstrated by x-rays and most of them seemed to gain in height.
Slovenian: Ta študija je pokazala, da se je otrokom, ki so prejemali zdravilo Strensiq, izboljšala struktura sklepov, kar so dokazali z rentgenskimi slikami, večina pa je pridobila tudi na telesni višini.
English: What are the risks associated with Strensiq?
Slovenian: Kakšna tveganja so povezana z zdravilom Strensiq?
English: Why is Strensiq authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Strensiq odobreno v EU?
English: The medicine is available as a solution for injection.
Slovenian: Na voljo je v obliki raztopine za injiciranje.
English: Some of the studies also looked at the dose of 1 mg/kg Strensiq given six times a week.
Slovenian: V nekaterih od njih so proučevali tudi zdravilo Strensiq v odmerku 1 mg/kg, dano šestkrat na teden.
English: This material will include a self-injection guide for patients, as well as an injection guide for parents or caregivers of children with the condition.
Slovenian: To gradivo bo vključevalo navodila za samoinjiciranje, namenjena bolnikom, in navodila za injiciranje, namenjena staršem in negovalcem otrok s to boleznijo.
English: This is because it has not been possible to obtain complete information about Strensiq due to the rarity of the disease.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: Other information about Strensiq
Slovenian: Druge informacije o zdravilu Strensiq
English: What information is still awaited for Strensiq?
Slovenian: Katere informacije o zdravilu Strensiq še pričakujemo?
English: For the full list of side effects and restrictions with Strensiq, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Strensiq glejte navodilo za uporabo.
English: Strensiq contains the active substance asfotase alfa.
Slovenian: Zdravilo Strensiq vsebuje učinkovino asfotaza alfa.
English: Strensiq can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing metabolic or bone disorders.
Slovenian: Predpisovanje in izdaja zdravila Strensiq je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem presnovnih ali kostnih bolezni.
English: How is Strensiq used?
Slovenian: Kako se zdravilo Strensiq uporablja?
English: How does Strensiq work?
Slovenian: Kako zdravilo Strensiq deluje?
English: These medicines include:
Slovenian: Ta zdravila vključujejo:
English: Safety and efficacy in children have not been established.
Slovenian: Varnost in učinkovitost pri otrocih nista bili dokazani.
English: if you are pregnant
Slovenian: • če ste noseči.
English: You should tell your doctor as soon as possible:
Slovenian: Svojemu zdravniku čim prej povejte, če imate:
English: Patients should be observed and given supportive treatment.
Slovenian: Bolnike je treba nadzirati in jim nuditi podporno zdravljenje.
English: Refer also to section 4.8.
Slovenian: Glejte tudi poglavje 4.8.
English: Always take your tablets with a drink of water.
Slovenian: Tablete vedno jemljite z vodo.
English: Refer to sections 4.3 and 4.5 for further information on bleeding risks.
Slovenian: Glejte poglavji 4.3 in 4.5 za več informacij o tveganju za krvavitve.