FrancophonIA/ELRC3.0 huggingface dataset:
English: Women using <invented name> should be specifically pointed out to contact their physician in case of possible symptoms of thrombosis.
Slovenian: Ženske, ki jemljejo zdravilo <ime zdravila>, je treba posebej opozoriti, da se morajo v primeru možnih simptomov tromboze posvetovati s svojim zdravnikom.
English: [This section should replace any existing one and should read as follows:]
Slovenian: [Trenutno odobrene indikacije je treba izbrisati in zamenjati z naslednjim besedilom:]
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use.
Slovenian: Če obstaja sum na dedno nagnjenost, je treba žensko pred odločitvijo za uporabo kateregakoli hormonskega kontraceptiva napotiti po nasvet k specialistu.
English: In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician.
Slovenian: Ženska naj se v primeru poslabšanja, ponovnega pojava ali prvega pojava katerega koli od teh stanj ali dejavnikov tveganja posvetuje s svojim zdravnikom.
English: • if you have (or have ever had) a migraine, with visual disturbances
Slovenian: • če imate (ali ste kdaj imeli) migreno z motnjami vida
English: • The risk of venous thromboembolic events increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Slovenian: • Tveganje za nastanek venskih trombemboličnih zapletov se povečuje s: - starostjo - kajenjem (tveganje se še dodatno poveča pri strastnih kadilkah in s starostjo, predvsem pri ženskah, starejših od 35 let.
English: • Symptoms of venous or arterial thrombosis or of a cerebrovascular accident can include: unusual unilateral leg pain and / or swelling; sudden severe pain in the chest, whether or not it radiates to the left arm; sudden breathlessness; sudden onset of coughing; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances; ‘acute' abdomen
Slovenian: • Simptomi venskih ali arterijskih tromboz ali cerebrovaskularnih dogodkov so lahko: nenavadne bolečine in/ali oteklost ene noge; nenadna huda bolečina v prsnem košu, ki se lahko širi v levo roko; nenadno težko dihanje; nenaden napad kašlja; vsak nenavaden, hud, dolgotrajen glavobol; nenadna delna ali popolna izguba vida; diplopija; nerazločno govorjenje ali afazija; vrtoglavica; kolaps z ali brez žariščnega epileptičnega napada; šibkost ali zelo izrazita omrtvelost, ki nenadoma prizadene eno stran ali en del telesa; motorične motnje; "akutni" abdomen.
English: When using a hormonal contraceptive like < invented name > you are strongly advised to stop smoking, especially if you are older than 35 years; if you are overweight; if you have high blood pressure; if a close relative has had a heart attack or stroke at a young age; if you have a high level of fat in your blood (cholesterol or triglycerides); if you get migraines; if you have a problem with your heart (valve disorder, disturbance of the rhythm).
Slovenian: Med uporabo hormonskih kontraceptivov, kot je zdravilo <ime zdravila>, vam strogo odsvetujemo kajenje, še posebej če ste starejši od 35 let; če ste predebeli če imate visok krvni tlak če je kdo od vaših bližnjih sorodnikov v mladosti imel srčni infarkt ali možgansko kap če imate zelo visoke vrednosti maščob v krvi (holesterola ali trigliceridov) če imate napade migrene; če imate težave s srcem (okvaro srčnih zaklopk, motnje srčnega ritma)
English: The use of a combined pill has been connected with an increased risk of clots in the arteries.
Slovenian: Uporabo kombiniranih kontraceptivov povezujejo tudi s povečanim tveganjem za nastanek krvnih strdkov v arterijah.
English: • Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
Slovenian: • venska tromboza, prisotna ali v anamnezi (globoka venska tromboza, pljučna embolija)
English: • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (see section 4.4) such as: o diabetes mellitus with vascular symptoms o severe hypertension o severe dyslipoproteinaemia
Slovenian: • prisotnost hudih ali več dejavnikov tveganja za vensko ali arterijsko trombozo (glejte poglavje 4.4), kot so: o sladkorna bolezen z zapleti na ožilju o huda hipertenzija o huda dislipoproteinemija
English: Section 4.3 Contraindications [The following contraindications related to thromboembolism should be included in this section]
Slovenian: 4.3 Kontraindikacije [Naslednje kontraindikacije je treba vključiti v to poglavje]
English: The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill.
Slovenian: Tveganje za nastanek krvnih strdkov v venah je največje prvo leto, ko ženska uporablja kombinirani kontraceptiv.
English: Using a combined pill increases a woman's risk of developing such clots compared with a woman not taking any combined pill.
Slovenian: Uporaba kombiniranega kontraceptiva pri ženski poveča tveganje za nastanek krvnih strdkov v primerjavi z ženskami, ki ne jemljejo kombiniranih kontraceptivov.
English: [The following to be included below the table of adverse reactions]
Slovenian: [Naslednje besedilo je treba vključiti v preglednico o neželenih učinkih]
English: • Arterial thromboembolic disorders
Slovenian: • arterijska trombembolija
English: The excess risk of VTE is highest during the first year a woman starts <invented name> or when restarting or switching after a pill-free interval of at least a month.
Slovenian: Povečano tveganje VTE je največje v prvem letu uporabe in sicer pri ženskah, ki so prvič začele uporabljati zdravilo <ime zdravila>, ali pri ženskah, ki so ga ponovno začele uporabljati ali so prešle nanj po vsaj enomesečnem premoru brez jemanja kontracepcijskih tablet.
English: Other medical conditions, which have been associated with adverse circulatory events, include diabetes mellitus, systemic lupus erythematosus, hemolytic uraemic syndrome, chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) and sickle cell disease.
Slovenian: Med drugimi boleznimi, ki jih povezujejo z neugodnimi vplivi na ožilje, so sladkorna bolezen, sistemski eritematozni lupus, hemolitično-uremični sindrom, kronična vnetna črevesna bolezen (Crohnova bolezen ali ulcerozni kolitis) in srpastocelična anemija.
English: It has a similar composition to that of a combined oral contraceptive (COC).
Slovenian: Zdravilo ima podobno sestavo kot kombinirani peroralni kontraceptivi.
English: How to take < invented name > [the wording below should be inserted in the relevant sections]
Slovenian: Kako jemati zdravilo <ime zdravila> [Spodnje besedilo je treba vstaviti v ustrezna poglavja]
English: • Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack).
Slovenian: • arterijska tromboza, prisotna ali v anamnezi (npr. miokardni infarkt) ali predhodna stanja (npr. angina pektoris in prehodni ishemični napad)
English: • Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal, cerebral or retinal veins and arteries, in hormonal contraceptive users.
Slovenian: • Izredno redko so pri uporabnicah hormonskih kontraceptivov, poročali o trombozi v drugih žilah, npr. jetrnih, mezenteričnih, ledvičnih, možganskih ali mrežničnih venah in arterijah.
English: For the treatment of acne, <invented name> should only be used after topical therapy or systemic antibiotic treatments have failed.
Slovenian: Zdravilo <ime zdravila> se lahko uporablja za zdravljenje aken le takrat, ko lokalno zdravljenje ali sistemsko zdravljenje z antibiotiki, nista bili uspešni.
English: Your doctor will also tell you when you can start using <invented name> again after you are back on your feet.
Slovenian: Vaš zdravnik vam bo tudi svetoval, kdaj po okrevanju lahko spet začnete uporabljati zdravilo <ime zdravila>.
English: Summary of Product Characteristics (SmPC)
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: • Presence or history of cerebrovascular accident
Slovenian: • cerebrovaskularni dogodek, prisoten ali v anamnezi
English: • There is an increased risk of thromboembolism for all women who use <invented name> (see section 4.4).
Slovenian: • Pri vseh ženskah, ki uporabljajo zdravilo <ime zdravila>, je tveganje za trombembolijo povečano (glejte poglavje 4.4).
English: • Venous thromboembolic disorders
Slovenian: • venska trombembolija
English: Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] <invented name> is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle.
Slovenian: Zdravilo <ime zdravila> vsebuje progestagen ciproteronacetat in estrogen etinilestradiol in se ga jemlje 21 dni v mesečnem ciklusu.
English: Your doctor may tell you to stop using <invented name> several weeks before surgery or while you are less mobile.
Slovenian: Vaš zdravnik vam bo morda svetoval, da nekaj tednov pred operacijo ali ko ste manj pokretni prenehate uporabljati zdravilo <ime zdravila>.
English: • if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism)
Slovenian: • če imate (ali ste kdaj imeli) krvni strdek v nogah (tromboza), pljučih (pljučna embolija) ali drugih delih telesa
English: • The use of <invented name> carries an increased risk of venous thromboembolism (VTE) compared with no use.
Slovenian: • Pri ženskah, ki uporabljajo zdravilo <ime zdravila>, je tveganje za pojav venske trombembolije (VTE) večje kot pri ženskah, ki ga ne uporabljajo.
English: an unusual sudden cough; severe pain in the chest which may reach the left arm; breathlessness; any unusual, severe, or long-lasting headache or worsening of migraine; partial or complete loss of vision, or double vision; slurring or speech disability; sudden changes to your hearing, sense of smell, or taste; dizziness or fainting; weakness or numbness in any part of your body; severe pain in your abdomen; severe pain or swelling in either of your legs.
Slovenian: Takoj nehajte jemati tablete in se posvetujte s svojim zdravnikom, če opazite kakršne koli znake, ki spremljajo nastanek krvnih strdkov, npr.: neobičajen, nenaden kašelj huda bolečina v prsnem košu, ki se lahko širi v levo roko težko dihanje vsak nenavaden, hud ali dolgotrajen glavobol ali poslabšanje migrene delna ali popolna izguba vida ali dvojni vid nerazločno govorjenje ali nezmožnost govorjenja nenadne spremembe sluha, spremenjen vonj ali okus omotica ali omedlevica šibkost ali omrtvelost katerega koli dela telesa hude bolečine v trebuhu hude bolečine ali oteklost ene noge
English: Blood clots in an artery
Slovenian: Krvni strdki v arteriji
English: Section 4.1 Therapeutic indications [The currently approved indications should be deleted and replaced by the following:] Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Slovenian: Zdravljenje zmernih do hudih aken, povezanih z občutljivostjo za androgene (z ali brez seboreje) in/ali hirzutizmom, pri ženskah v rodni dobi.
English: Blood clots in a vein
Slovenian: Krvni strdki v venah
English: - hypertension; - migraine; - valvular heart disease; - atrial fibrillation; - a positive family history (arterial thrombosis ever in a sibling or parent at a relatively early age).
Slovenian: če želijo jemati zdravilo <ime zdravila>) - dislipoproteinemijo - debelostjo (indeks telesne mase več kot 30 kg/m²) - hipertenzijo - migreno - boleznijo srčnih zaklopk - atrijsko fibrilacijo - pozitivno družinsko anamnezo (tj. z arterijsko trombozo pri sorojencu ali katerem od staršev v sorazmerno zgodnji starosti).
English: [The wording below should be inserted in this section] When should you contact your doctor
Slovenian: Opozorila in previdnostni ukrepi [Spodnje besedilo je treba vstaviti v to poglavje] Kdaj se morate posvetovati z zdravnikom
English: Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Slovenian: Zaradi teratogenosti antikoagulantnega zdravljenja (kumarinov) je treba uporabljati drugo ustrezno kontracepcijsko metodo.
English: • if you have (or have ever had) a heart attack or stroke
Slovenian: • če imate (ali ste kdaj v preteklosti imeli) srčni infarkt ali možgansko kap
English: Antithrombotic treatment should be considered if the use of <invented name> has not been discontinued in advance.
Slovenian: Če jemanje zdravila <ime zdravila> ni prekinjeno vnaprej, je treba razmisliti o antitrombotičnem zdravljenju.
English: Circulatory disorders
Slovenian: KLINIČNI PODATKI
English: The following serious adverse events have been reported in women using <invented name>, which are discussed in section 4.4 Special warning and precautions for use:
Slovenian: • Žilne bolezni, redke (≥ 1/10.000 do < 1/1.000): trombembolija [Naslednje besedilo je treba vključiti pod preglednico o neželenih učinkih] Pri ženskah, ki uporabljajo zdravilo <ime zdravila>, so poročali o naslednjih resnih neželenih učinkih, ki so podrobneje navedeni v poglavju 4.4 Posebna opozorila in previdnostni ukrepi:
English: Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot.
Slovenian: Če opazite kakršne koli znake, ki spremljajo nastanek krvnih strdkov, takoj prenehajte jemati tablete in se posvetujte s svojim zdravnikom.
English: Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - dyslipoproteinemia; - obesity (body mass index over 30 kg/m2);
Slovenian: Ženskam po 35. letu je treba strogo odsvetovati kajenje, če želijo jemati zdravilo <ime zdravila>).
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Slovenian: Tveganje za nastanek arterijskih trombemboličnih zapletov ali cerebrovaskularnega dogodka se povečuje s: - starostjo
English: Tell your doctor if any of the following conditions applies to you before starting to use <invented name>.
Slovenian: Preden boste začeli jemati zdravilo <ime zdravila>, obvestite zdravnika, če kar koli od naštetega velja za vas.
English: (e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke' (transient ischaemic attack)
Slovenian: • če imate (ali ste kdaj imeli) bolezen, ki lahko napoveduje srčni napad (npr angina pektoris, ki povzroča hudo bolečino v prsnem košu) ali rahlo možgansko kap" (prehodni ishemični napad)
English: What you need to know before you use < invented name > [The wording below should be inserted in the relevant sections]
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila>
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any hormonal contraceptive use; - prolonged immobilisation, major surgery, any surgery to the legs, or major trauma.
Slovenian: - dolgotrajno imobilizacijo, večjo operacijo, vsako operacijo nog ali večjo poškodbo.
English: The main measure of effectiveness was the average change in the blood pressure.
Slovenian: Glavno merilo učinkovitosti je bila povprečna sprememba v krvnem tlaku.
English: In addition, one main study was carried out in around 1,200 patients with essential hypertension.
Slovenian: Izvedena je bila tudi ena glavna študija, v katero je bilo vključenih okoli 1 200 bolnikov z esencialno hipertenzijo.
English: The application was withdrawn at ‘day 180'.
Slovenian: Vloga je bila umaknjena na 180. dan postopka.
English: It was to be available as film-coated tablets.
Slovenian: Na voljo naj bi bilo v obliki filmsko obloženih tablet.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Slovenian: To pomeni, da je CHMP ovrednotil dokumentacijo, ki jo je družba predložila, in pripravil seznam vprašanj.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Slovenian: Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „Vsi dokumenti“.
English: The two active substances in Rasival are anti-hypertensive medicines that are already in use in the European Union (EU).
Slovenian: Obe zdravilni učinkovini v zdravilu Rasival sta antihipertenzivni zdravili, ki se v Evropski uniji (EU) že uporabljata.
English: The effects of Rasival were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Rasival so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The company presented results of studies designed to show that the tablet containing the two substances is absorbed in the body in the same way as the separate tablets.
Slovenian: Družba je predstavila rezultate študij, s katerimi je želela dokazati, da tablete, ki vsebujejo obe zdravilni učinkovini, telo absorbira na enak način kot dve posamezni tableti.
English: Withdrawal of the marketing authorisation application for Rasival (aliskiren / valsartan) EMA/584655/2010
Slovenian: Umik vloge za dovoljenje za promet z zdravilom Rasival (aliskiren/valsartan) EMA/584655/2010
English: Aliskiren reduces the production of the angiotensin II (a hormone that narrows blood vessels), while valsartan blocks the receptors to which angiotensin II normally attaches.
Slovenian: Aliskiren znižuje proizvajanje angiotenzina II (hormon, ki zožuje krvne žile), medtem ko valsartan zavira receptorje, na katere se angiotenzin II običajno veže.
English: The CHMP wanted further studies to be carried out on how Rasival behaved in the body, specifically after a patient has eaten food.
Slovenian: CHMP je želel, da se izvedejo še nadaljnje študije o delovanju zdravila Rasival v telesu, zlasti po zaužiti hrani.
English: The company had not yet responded to the last round of questions at the time of the withdrawal.
Slovenian: Ob umiku vloge družba na zadnji sklop vprašanj še ni odgovorila.
English: In addition, the CHMP was not convinced that the company had demonstrated that the combination of aliskiren and valsartan is widely used in clinical practice.
Slovenian: CHMP prav tako ni bil prepričan, da je družba ustrezno dokazala, da se zdravljenje s kombinacijo aliskirena in valsartana v klinični praksi pogosto uporablja.
English: On 15 September 2010, Novartis Europharm Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rasival, for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately.
Slovenian: Družba Novartis Europharm Limited je dne 15. septembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Rasival, namenjenemu zdravljenju esencialne hipertenzije pri odraslih bolnikih, pri katerih se krvni tlak ustrezno uravnava s kombinacijo aliskirena in valsartana, ki se jemljeta ločeno.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes, as there are no ongoing trials with Rasival.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih ali v programih sočutne uporabe, saj z zdravilom Rasival trenutno ne potekajo nobena preskušanja.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rasival could not have been approved for the treatment of essential hypertension.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Rasival za zdravljenje esencialne hipertenzije ni mogoče odobriti.
English: What was Rasival expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Rasival uporabljalo?
English: How is Rasival expected to work?
Slovenian: Kako naj bi zdravilo Rasival delovalo?
English: Rasival was expected to be used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren and valsartan taken separately.
Slovenian: Zdravilo Rasival naj bi se uporabljalo za zdravljenje esencialne hipertenzije (visok krvni tlak) pri odraslih, pri katerih se krvni tlak že ustrezno uravnava s kombinacijo aliskirena in valsartana, ki se jemljeta ločeno.
English: By blocking the activity of angiotensin II, Rasival acts to widen blood vessels and so lower blood pressure.
Slovenian: Z zaviranjem delovanja angiotenzina II zdravilo Rasival vpliva na razširjanje krvnih žil in tako znižuje krvni tlak.
English: Withdrawal of the marketing authorisation application for Rasival (aliskiren / valsartan)
Slovenian: Umik vloge za dovoljenje za promet z zdravilom Rasival (aliskiren/valsartan)
English: Patients received either Rasival or a medicine containing only one of the active substances, aliskiren or valsartan, for eight weeks.
Slovenian: Bolniki so osem tednov prejemali zdravilo Rasival ali zdravilo, ki vsebuje le eno izmed dveh zdravilnih učinkovin, aliskiren ali valsartan.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion the company had not provided enough scientific data to support the application for Rasival.
Slovenian: Tako je CHMP v času umika vloge menil, da družba v podporo vlogi za dovoljenje za promet z zdravilom Rasival ni predložila zadostnih znanstvenih podatkov.
English: Rasival is a medicine that contains the active substances aliskiren and valsartan.
Slovenian: Rasival je zdravilo, ki vsebuje zdravilni učinkovini aliskiren in valsartan.
English: What is Rasival?
Slovenian: Kaj je zdravilo Rasival?
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015
Slovenian: Datum prve odobritve: 28. februar 2011 Datum zadnjega podaljšanja: 24.
English: Children and adolescents Daliresp should not be used by children and adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Daliresp se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: You may need to take Daliresp for several weeks to achieve its beneficial effect.
Slovenian: Morda boste morali jemati zdravilo Daliresp več tednov, da doseže svoj ugoden učinek.
English: If on one day you have forgotten to take a tablet of Daliresp, just carry on the next day with the next tablet as usual.
Slovenian: Če ste na določen dan pozabili vzeti tableto zdravila Daliresp, potem naslednji dan samo nadaljujte z naslednjo tableto kot običajno.
English: In case of an allergic reaction, stop taking Daliresp and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Slovenian: V primeru pojava alergijske reakcije nemudoma prenehajte jemati zdravilo Daliresp in se nemudoma posvetujte z zdravnikom ali poiščite nujno zdravniško pomoč na urgentnem oddelku najbližje bolnišnice.
English: Daliresp may need to be taken for several weeks to achieve its effect (see section 5.1).
Slovenian: Zdravilo Daliresp je treba jemati nekaj tednov, preden doseže svoj učinek (glejte poglavje 5.1).
English: Do not take Daliresp - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Slovenian: Ne jemljite zdravila Daliresp - če ste alergični na roflumilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6).