FrancophonIA/ELRC3.0 huggingface dataset:
English: Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg: Each tablet contains the following inactive ingredients: microcrystalline cellulose(E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose(E464).
Slovenian: Cozaar Comp 50 mg/12,5 mg, Cozaar Comp 100 mg/12,5 mg in Cozaar Comp 100 mg/25 mg: Vsaka tableta vsebuje naslednje pomožne snovi: mikrokristalno celulozo (E460), laktozo monohidrat, predgelirani koruzni škrob, magnezijev stearat (E572), hidroksipropilcelulozo (E463), hipromelozo (E464).
English: There was no clinically significant effect on the plasma concentration profile of losartan when the drug was administered with a standardized meal.
Slovenian: Zaužitje zdravila med standardiziranim obrokom ni imelo nobenega klinično pomembnega vpliva na plazemski koncentracijski profil losartana.
English: Metabolism and nutrition disorders Uncommon: Anorexia, hyperglycaemia, hyperuricaemia, hypokalaemia, hyponatraemia
Slovenian: Presnovne in prehranske motnje občasne: anoreksija, hiperglikemija, hiperurikemija, hipokaliemija, hiponatriemija Psihiatrične motnje občasne: nespečnost
English: Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Slovenian: Diuretično zdravljenje s tiazidi lahko povzroči dvig koncentracije holesterola in trigliceridov.
English: Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating
Slovenian: Bolezni kože in podkožja občasne: alopecija, dermatits, suha koža, eritem, zardevanje, fotosenzitivnost, srbenje, izpuščaj, koprivnica, znojenje
English: Cases of thrombocytopenia in neonates and fetal or neonatal jaundice were reported after treating the mothers with thiazides.
Slovenian: Po zdravljenju mater s tiazidi v nosečnosti so poročali o primerih trombocitopenije pri novorojenčkih ter o fetalni in neonatalni zlatenici.
English: • Some antipsychotics (eg thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).
Slovenian: • nekateri antipsihotiki (npr. tioridazin, klorpromazin, levomepromazin, trifluoperazin,
English: Therefore, serum lithium levels should be monitored carefully if lithium salts are to be coadministered with angiotensin II receptor antagonists.
Slovenian: Zato je treba v primeru, ko mora bolnik sočasno z antagonisti receptorjev angiotenzina II jemati litijeve soli, pozorno spremljati količino litija v serumu.
English: Take special care with Cozaar Comp • if you have previously suffered from swelling of the face, lips, throat or tongue
Slovenian: • če so vam kdaj otekali obraz, ustnice, žrelo ali jezik.
English: COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
Slovenian: COZAAR COMP filmsko obložene tablete kalijev losartanat in hidroklorotiazid
English: Anaphylactic reaction
Slovenian: Redke: anafilaktična reakcija
English: Common: Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogoste: kašelj, okužba zgornjih dihal, zamašen nos, sinuzitis, težave s sinusi občasne: nelagodje v žrelu, faringitis, laringitis, dispneja, bronhitis, krvavitev iz nosu, rinitis, respiratorna kongestija
English: Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Slovenian: Cozaar Comp 50 mg/12,5 mg in Cozaar Comp 100 mg/25 mg vsebujeta tudi titanov dioksid (E171), kinolinsko rumeno (E104) in karnauba vosek (E903).
English: Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Slovenian: Cozaar Comp 50 mg/12,5 mg vsebuje 4,24 mg (0,108 mEq) kalija.
English: Cozaar Comp 100 mg/25 mg is supplied as unscored film-coated tablets.
Slovenian: Cozaar Comp 100 mg/25 mg je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze.
English: Despite the significant decrease in blood pressure, administration of Cozaar Comp had no clinically significant effect on heart rate.
Slovenian: Zdravljenje z zdravilom Cozaar Comp ni imelo klinično pomembnega vpliva na srčno frekvenco kljub pomembnemu znižanju krvnega tlaka.
English: Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Slovenian: Madžarska Merck Sharp & Dohme Hungary Ltd
English: There was no evidence of teratogenicity in rats or rabbits treated with the losartan/hydrochlorothiazide combination.
Slovenian: Pri podganah ali kuncih, ki so prejemali kombinacijo losartan/hidroklorotiazid, niso odkrili teratogenosti.
English: Cozaar Plus 100/12,5 100 mg losartan potassium12.5 mg hydrochlorothiazide
Slovenian: Cozaar Plus 100/12,5 100 mg kalijev losartanat
English: Cozaar Comp 100 mg/25 mg> contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Slovenian: Cozaar Comp 100 mg/25 mg kot zdravilni učinkovini vsebuje 100 mg kalijevega losartanata in 25 mg hidroklorotiazida.
English: Ear and labyrinth disorders Uncommon: Vertigo, tinnitus
Slovenian: Ušesne bolezni in motnje labirinta Občasne: vrtoglavica, tinitus
English: Norway MSD BV Waarderweg 39
Slovenian: MSD BV Waarderweg 39 2031 BN Haarlem Nizozemska
English: Cozaar Comp 100 mg/12.5 mg mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
Slovenian: Cozaar Comp 100 mg/12,5 mg in Cozaar Comp 100 mg/25 mg vsebujeta 8,48 mg (0,216 mEq) kalija.
English: HYZAAR (Losartan/Hydrochlorothia zide)
Slovenian: HYZAAR (Losartan/Hidroklorotiazid)
English: • if you have ‘aortic or mitral valve stenosis' (narrowing of the valves of the heart) or
Slovenian: • če imate stenozo aortne ali mitralne zaklopke (zožitev srčnih zaklopk) ali hipertrofično kardiomiopatijo (bolezen, ki povzroča zadebelitev srčne mišice).
English: Cozaar Comp 100 mg/12.5 mg mg is supplied as unscored film-coated tablets.
Slovenian: Cozaar Comp 100 mg/12,5 mg je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze.
English: Cosaar Plus - Filmtabletten 50 mg losartan potassium12.5 mg hydrochlorothiazide
Slovenian: Cosaar Plus - Filmtabletten 50 mg kalijev losartanat
English: Fortzaar 100 mg/25 mg 100 mg losartan potassium25 mg hydrochlorothiazide
Slovenian: Fortzaar 100 mg/25 mg 100 mg kalijev losartanat
English: Anaphylactic reactions, angioedema, urticaria
Slovenian: Bolezni imunskega sistema redke: anafilaktične reakcije, angioedem, koprivnica
English: Cozaar Comp 50 mg/12.5 mg> contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Slovenian: Cozaar Comp 50 mg/12,5 mg kot zdravilni učinkovini vsebuje 50 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
English: Unless continued Losartan/HTCZ therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Slovenian: Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje s kombinacijo losartan/HCTZ nujno.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg mg film-coated tablets Losartan and hydrochlorothiazide
Slovenian: Cozaar Comp 100 mg/25 mg filmsko obložene tablete losartan in hidroklorotiazid
English: Cozaar Comp100 mg/12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Slovenian: Cozaar Comp 100 mg/12,5 mg kot zdravilni učinkovini vsebuje 100 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
English: Marketing Authorisation Holder and Manufacturer <To be completed nationally>
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Izpolni država članica]
English: The efficacy and safety are established for the indication “treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy”.
Slovenian: - Zdravljenje esencialne hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče primerno nadzorovati z monoterapijo s hidroklorotiazidom ali losartanom Učinkovitost in varnost sta bili ugotovljeni za indikacijo „zdravljenje esencialne hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče primerno nadzorovati z monoterapijo s hidroklorotiazidom ali losartanom“.
English: Hyzaar Forte 100/25 mg 100 mg losartan potassium25 mg hydrochlorothiazide
Slovenian: Hyzaar Forte 100/25 mg 100 mg kalijev losartanat
English: The CHMP concluded that the indication for the initial therapy of hypertension with the fixed dose combination (FDC) does not have a positive benefit-risk ratio, and therefore is not acceptable.
Slovenian: -Kot prvi korak pri zdravljenju bolnikov z zmerno do hudo hipertenzijo in pri bolnikih s hudo ali zelo hudo hipertrofijo levega ventrikla CHMP je zaključil, da indikacija za začetno zdravljenje hipertenzije s fiksno kombinacijo odmerkov nima pozitivnega razmerja med koristnimi učinki in tveganjem, zaradi česar ni sprejemljiva.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 50 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
English: Hepato-biliary disorders Not known: Liver function abnormalities
Slovenian: Bolezni jeter, žolčnika in žolčevodov Pogostnost ni znana: nenormalno delovanje jeter
English: Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity; concomitant use is not recommended.
Slovenian: Diuretiki zmanjšajo ledvični očistek litija in s tem zelo povečajo tveganje za toksičnost litija.
English: and Cozaar Comp 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.
Slovenian: Cozaar Comp 100 mg/25 mg vsebuje 8,48 mg (0,216 mEq) kalija.
English: • Symtomatic hyperuricaemia/gout
Slovenian: • Simptomatska hiperurikemija/protin.
English: Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Slovenian: Vsaka tableta kot zdravilni učinkovini vsebuje 100 mg losartana (v obliki kalijeve soli) in 25 mg hidroklorotiazida (HCTZ).
English: COZAAR-COMP Forte 100 mg losartan potassium25 mg hydrochlorothiazide
Slovenian: COZAAR-COMP Forte 100 mg kalijev losartanat
English: HYZAAR 50 mg/12,5 mg 50 mg losartan potassium12.5 mg hydrochlorothiazide
Slovenian: HYZAAR 50 mg/12,5 mg; 50 mg kalijev losartanat
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg Losartan and hydrochlorothiazide
Slovenian: Cozaar Comp 100 mg/25 mg losartan in hidroklorotiazid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 100 mg kalijevega losartanata in 25 mg hidroklorotiazida.
English: • Severe hepatic impairment; Cholestasis and biliary obstructive disorders
Slovenian: • Huda okvara jeter, holestaza, obstrukcija žolča.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 100 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
English: Cozaar Comp 100 mg/12.5 mg mg contains 8.48 mg (0.216 mEq) of potassium.
Slovenian: Cozaar Comp 100 mg/12,5 mg vsebuje 8,48 mg (0,216 mEq) kalija.
English: • Anuria
Slovenian: • Anurija.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg Losartan and hydrochlorothiazide
Slovenian: Cozaar Comp 50 mg/12,5 mg losartan in hidroklorotiazid
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Slovenian: Cozaar Comp 50 mg/12,5 mg filmsko obložene tablete losartan in hidroklorotiazid
English: What Cozaar Comp contains
Slovenian: Kaj vsebuje zdravilo Cozaar Comp
English: Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia.
Slovenian: Tako kombinacija losartana in hidroklorotiazida teži k zniževanju z diuretikom povzročene hiperurikemije.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg Losartan and hydrochlorothiazide
Slovenian: Cozaar Comp 100 mg/12,5 mg losartan in hidroklorotiazid
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Slovenian: Cozaar Comp 100 mg/12,5 mg filmsko obložene tablete losartan in hidroklorotiazid
English: Liver function impairment
Slovenian: Okvara jeter
English: Merck Sharp & Dohme Italia S.p.A. via G Fabbroni 6 , 00191 Rome Italy
Slovenian: Via G. Fabbroni 6, 00191 Rim, Italija
English: Each tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Slovenian: Vsaka tableta kot zdravilni učinkovini vsebuje 50 mg losartana (v obliki kalijeve soli) in 12,5 mg hidroklorotiazida (HCTZ).
English: Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Slovenian: Vsaka tableta kot zdravilni učinkovini vsebuje 100 mg losartana (v obliki kalijeve soli) in 12,5 mg hidroklorotiazida (HCTZ).
English: • Diarrhoea, abdominal pain, nausea, indigestion,
Slovenian: • driska, bolečine v trebuhu, siljenje na bruhanje, slaba prebava
English: Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Slovenian: Cozaar Comp 50 mg/12,5 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 ali 280 tablet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/12.5 mg film-coated tablets HDPE bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar Comp 100 mg/12,5 mg filmsko obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 50 mg/12.5 mg film-coated tablets HDPE Bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar Comp 50 mg/12,5 mg filmsko obložene tablete
English: 100 mg/12,5 mg filmcoated tablets
Slovenian: 100 mg/12,5 mg film-coated tablets
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/25 mg film-coated tablets HDPE bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za Cozaar Comp 100 mg/25 mg filmsko obložene tablete
English: Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Slovenian: Cozaar Comp 100 mg/12,5 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablet.
English: Skin and subcutaneous tissue disorders
Slovenian: Holestiraminske in kolestipolne smole
English: Nervous system disorders
Slovenian: Bolezni imunskega sistema
English: Cozaar Comp 100 mg/25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Slovenian: Cozaar Comp 100 mg/25 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 14, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Slovenian: Med zdravljenjem s tiazidi se lahko prikaže do tedaj prikrita sladkorna bolezen.
English: Heart failure:
Slovenian: Srčno popuščanje
English: In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy.
Slovenian: Antihipertenzivni učinek traja do 24 ur.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/25 mg film-coated tablets
Slovenian: Nalepka za HDPE plastenko za Cozaar Comp 100 mg/25 mg filmsko obložene tablete
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Slovenian: [spodaj navedene trenutno odobrene indikacije je treba izbrisati (specifično besedilo indikacije se lahko razlikuje od izdelka do izdelka)]
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Slovenian: • Simptomatsko zdravljenje kroničnih patoloških kognitivnih in nevrosenzoričnih motenj pri starostnikih (razen Alzheimerjeve bolezni in drugih demenc)
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Slovenian: • Pomožno zdravljenje zmanjšanja vidne ostrine in motenj vidnega polja, ki so domnevno žilnega izvora
English: All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Slovenian: Vse navedbe zgoraj navedenih indikacij je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Slovenian: Vse navedbe zgoraj navedenih indikacij je treba izbrisati iz ustreznih poglavij navodil za uporabo.
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Slovenian: Spremembe ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
English: Intrarosa prasterone
Slovenian: Intrarosa prasteron
English: The medicine has an acceptable safety profile.
Slovenian: Zdravilo ima sprejemljiv varnostni profil.
English: In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks.
Slovenian: V obeh študijah so dajali 6,5 mg zdravila Intrarosa enkrat dnevno 12 tednov.
English: What measures are being taken to ensure the safe and effective use of Intrarosa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Intrarosa?
English: The full EPAR for Intrarosa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Intrarosa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Intrarosa.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Intrarosa must not be used in patients with the following conditions: genital bleeding where the cause has not been diagnosed, known or suspected breast cancer or oestrogen-dependent cancer, previous breast cancer, untreated endometrial hyperplasia (thickening of the lining of the womb), acute (shortterm) liver disease, previous liver disease where liver function tests are still abnormal, previous or current venous thromboembolism (formation of blood clots in the veins), thrombophilic disorders (abnormal blood clotting), active or recent arterial thromboembolic disease (disease caused by blood clots in the arteries), porphyria (inability to break down chemicals called porphyrins).
Slovenian: Zdravilo Intrarosa se ne sme uporabljati pri bolnicah z naslednjimi stanji: nepojasnjena genitalna krvavitev, znan rak dojk ali rak, ki je občutljiv na estrogene, ali sum nanju, pretekli rak dojk, nezdravljena hiperplazija endometrija (zadebeljena maternična sluznica), akutna (kratkotrajna) bolezen jeter, pretekla bolezen jeter (če so testi delovanja jeter še vedno nenormalni), pretekla ali sedanja venska tromboza (tvorjenje krvnih strdkov v venah), trombofilne bolezni (nenormalno strjevanje krvi), aktivna ali nedavna arterijska trombembolična bolezen (bolezen, ki jo povzročijo krvni strdki v arterijah), porfirija (nezmožnost razgradnje kemikalij, imenovanih porfirini).
English: Other information about Intrarosa
Slovenian: Druge informacije o zdravilu Intrarosa
English: Pain during sexual intercourse was self-assessed by patients using a standard scale ranging from 0 (no pain) to 3 (severe pain).
Slovenian: Bolečino med spolnim odnosom so bolnice ocenile same s standardno lestvico v razponu od 0 (brez bolečine) do 3 (močna bolečina).
English: The European Medicines Agency therefore considered that Intrarosa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Intrarosa večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Intrarosa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Intrarosa.
English: The company that markets Intrarosa is required to conduct a study on how the medicine is used in clinical practice, including whether it is used according to the authorised product information.
Slovenian: Družba, ki trži zdravilo Intrarosa, mora izvesti študijo o tem, kako se zdravilo uporablja v klinični praksi in ali se uporablja v skladu z odobrenimi informacijami o zdravilu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intrarosa have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Intrarosa upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What benefits of Intrarosa have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Intrarosa izkazalo v študijah?
English: Why is Intrarosa approved?
Slovenian: Zakaj je bilo zdravilo Intrarosa odobreno?
English: What are the risks associated with Intrarosa?
Slovenian: Kakšna tveganja so povezana z zdravilom Intrarosa?
English: For more information about treatment with Intrarosa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Intrarosa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Intrarosa is available as a 6.5 mg pessary.
Slovenian: Zdravilo Intrarosa je na voljo v obliki 6,5-miligramske vaginalne globule.
English: Women should insert the pessary into their vagina, once daily, at bedtime.
Slovenian: Ženske naj vaginalno globulo vstavijo v vagino enkrat dnevno pred spanjem.
English: The most common side effect with Intrarosa (which may affect up to 1 in 10 people) is vaginal discharge.
Slovenian: Najpogostejši neželeni učinek zdravila Intrarosa (ki se lahko pojavi pri največ 1 bolnici od 10) je vaginalni izcedek.
English: Two studies involving 813 post-menopausal women with vulvar and vaginal atrophy found that treatment with Intrarosa was more effective than placebo (a dummy treatment) at reducing signs of thinning (atrophy) of vaginal tissues.
Slovenian: V dveh glavnih študijah z 813 ženskami po menopavzi z atrofijo vulve in vagine so ugotovili, da je zdravljenje z zdravilom Intrarosa učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri zmanjšanju znakov tanjšanja (atrofije) tkiva vagine.
English: Intrarosa contains the active substance prasterone, also known as dehydroepiandrosterone (DHEA).
Slovenian: Zdravilo Intrarosa vsebuje zdravilno učinkovino prasteron, znano tudi kot dehidroepiandrosteron (DHEA).
English: What is Intrarosa and what is it used for?
Slovenian: Kaj je zdravilo Intrarosa in za kaj se uporablja?