FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for NutropinAq.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NutropinAq.
English: • children who fail to grow because of a lack of growth hormone;
Slovenian: • otrok z motnjami v rasti zaradi pomanjkanja rastnega hormona;
English: The dose may need to be adjusted over time, depending on the patient's response, age and body weight.
Slovenian: Odmerek bo morda treba sčasoma prilagoditi glede na bolnikov odziv, starost in spremembo telesne mase.
English: NutropinAq produced better growth in children than would have been expected without treatment.
Slovenian: Zdravilo NutropinAq je pri otrocih povzročilo večjo rast, kot bi jo bilo pričakovati brez zdravljenja.
English: The doctor calculates the dose for each patient individually depending on the patient's condition.
Slovenian: Zdravnik za vsakega bolnika posebej izračuna ustrezni odmerek glede na njegovo zdravstveno stanje.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Slovenian: Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri se v bakterijo vstavi gen (DNK), ki ji omogoča tvorbo somatropina.
English: For more information about treatment with NutropinAq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom NutropinAq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP concluded that NutropinAq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila NutropinAq večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Other information about NutropinAq
Slovenian: Druge informacije o zdravilu NutropinAq
English: The medicine is given once a day by injection under the skin, using the injection pen specially designed for the NutropinAq cartridge.
Slovenian: Zdravilo se daje enkrat na dan z injiciranjem pod kožo, pri čemer se uporabi injekcijski peresnik, ki je oblikovan posebej za vložek zdravila NutropinAq.
English: NutropinAq has been studied in children with growth failure caused by a lack of growth hormone (230 patients), Turner syndrome (117 patients) or kidney disease (195 patients).
Slovenian: Zdravilo NutropinAq so proučevali pri otrocih z motnjami v rasti zaradi pomanjkanja rastnega hormona (230 bolnikov), Turnerjevega sindroma (117 bolnikov) ali obolenja ledvic (195 bolnikov).
English: Each cartridge contains 10 mg of the active substance somatropin.
Slovenian: En vložek vsebuje 10 mg zdravilne učinkovine somatropin.
English: What benefit has NutropinAq shown during the studies?
Slovenian: Kakšne koristi je zdravilo NutropinAq izkazalo med študijami?
English: The patient or their carer can inject NutropinAq after training by a doctor or a nurse.
Slovenian: Bolnik ali negovalec lahko zdravilo NutropinAq vbrizgata sama, potem ko sta ju medicinska sestra ali zdravnik za to ustrezno usposobila.
English: NutropinAq was compared with a placebo (a dummy treatment) or with a group of untreated patients, except in the studies of children with a lack of growth hormone where there was no comparison with any other group.
Slovenian: Zdravilo NutropinAq so primerjali s placebom (zdravilom brez zdravilne učinkovine) ali s skupino predhodno nezdravljenih bolnikov, razen v študijah pri otrocih s pomanjkanjem rastnega hormona, pri katerih ni bilo primerjave z drugo skupino.
English: Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be started or adjusted.
Slovenian: Med zdravljenjem je treba nadzorovati ravni sladkorja v krvi, lahko pa bo morda treba uvesti zdravljenje z insulinom ali pa prilagoditi že obstoječe insulinsko zdravljenje.
English: NutropinAq treatment should be started and supervised by a doctor who has experience in the management of patients with growth disorders.
Slovenian: Zdravljenje z zdravilom NutropinAq lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami v rasti.
English: NutropinAq must not be used in people who are hypersensitive (allergic) to somatropin or any of the other ingredients.
Slovenian: Zdravila NutropinAq ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) somatropin ali katero koli drugo sestavino zdravila.
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 NutropinAq.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo NutropinAq, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: • girls from 2 years old who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Slovenian: • deklic po 2. letu starosti, ki so premajhne rasti zaradi Turnerjevega sindroma (redke genske okvare, ki prizadene dekleta), ki je bil potrjen s kromosomsko analizo (analizo DNK);
English: The active substance in NutropinAq, somatropin, is identical to human growth hormone.
Slovenian: Zdravilna učinkovina zdravila NutropinAq, somatropin, je enaka človeškemu rastnemu hormonu.
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Slovenian: Ta hormon spodbuja rast v otroštvu in obdobju pubertete ter vpliva tudi na presnovo beljakovin, maščob in ogljikovih hidratov.
English: Other side effects seen at this lower frequency are reactions at the injection site, headache, hypertonia (muscle tension), hypothyroidism (under-activity of the thyroid gland), impaired glucose tolerance, asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq).
Slovenian: Drugi neželeni učinki, opaženi z enako nizko pogostostjo, so reakcije na mestu injiciranja, glavobol, hipertonija (napetost v mišicah), hipotiroidizem (nezadostno delovanje ščitnice), motena toleranca za glukozo, astenija (šibkost) ter razvoj protiteles (beljakovin, ki se pojavijo kot odziv na zdravilo NutropinAq).
English: NutropinAq replaces the natural hormone.
Slovenian: Zdravilo NutropinAq je nadomestek za naravni hormon.
English: The most serious side effects reported were the development of neoplasms (tumours) and intracranial hypertension (increased pressure inside the skull).
Slovenian: Najresnejša neželena učinka, ki sta bila opažena, sta pojav neoplazem (tumorjev) in intrakranialna hipertenzija (povišan tlak znotraj lobanje).
English: For the full list of all side effects reported with NutropinAq, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NutropinAq, glejte navodilo za uporabo.
English: What is the risk associated with NutropinAq?
Slovenian: Kakšna tveganja so povezana z zdravilom NutropinAq?
English: In adults, the most common side effects with NutropinAq (seen in more than 1 patient in 10) are myalgia (muscle pain), arthralgia (joint pain) and oedema (swelling).
Slovenian: Pri odraslih so najpogostejši neželeni učinki zdravila NutropinAq (opaženi pri več kot 1 bolniku od 10) mialgija (bolečine v mišicah), artralgija (bolečine v sklepih) in edem (oteklina).
English: NutropinAq must not be used for growth promotion in children with closed epiphyses (when the large bones have finished growing).
Slovenian: Prav tako se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami (tj. po končani rasti velikih kosti).
English: NutropinAq has also been studied in 171 adults with growth hormone deficiency.
Slovenian: Proučevali so ga tudi pri 171 odraslih s pomanjkanjem rastnega hormona.
English: In adults, NutropinAq increased lean body mass and reduced total body fat.
Slovenian: Pri odraslih je zdravilo NutropinAq povečalo brezmaščobno telesno maso in zmanjšalo skupno telesno maščevje.
English: • children (before puberty) who fail to grow because of long-lasting kidney disease, up to the time when they receive a kidney transplant.
Slovenian: • otrok (pred puberteto), ki zaradi kronične odpovedi ledvic zaostajajo v rasti, do presaditve ledvice.
English: NutropinAq must not be used when the patient has an active tumour or a lifethreatening illness.
Slovenian: Ne smejo ga uporabljati bolniki, ki imajo aktiven tumor ali smrtno nevarno bolezen.
English: The main measures in the adult study were lean body mass and the decrease in total body fat.
Slovenian: Glavni merili v študiji pri odraslih sta bili brezmaščobna telesna masa in zmanjšanje skupnega telesnega maščevja.
English: Somatropin may interfere with the body's use of insulin.
Slovenian: Somatropin lahko vpliva na presnovo insulina v telesu.
English: Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Slovenian: Rastni hormon je snov, ki jo izloča žleza na možganskem dnu, imenovana hipofiza.
English: They should use a different injection site each day.
Slovenian: Za injiciranje zdravila je treba vsak dan izbrati drug predel telesa.
English: NutropinAq is a solution for injection in a cartridge.
Slovenian: Zdravilo NutropinAq je raztopina za injiciranje v vložkih.
English: Why has NutropinAq been approved?
Slovenian: Zakaj je bilo zdravilo NutropinAq odobreno?
English: NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
Slovenian: Zdravilo NutropinAq se uporablja tudi za zdravljenje odraslih, ki jim primanjkuje rastnega hormona.
English: What is NutropinAq?
Slovenian: Kaj je zdravilo NutropinAq?
English: How has NutropinAq been studied?
Slovenian: Kako je bilo zdravilo NutropinAq raziskano?
English: What is NutropinAq used for?
Slovenian: Za kaj se zdravilo NutropinAq uporablja?
English: How is NutropinAq used?
Slovenian: Kako se zdravilo NutropinAq uporablja?
English: How does NutropinAq work?
Slovenian: Kako zdravilo NutropinAq deluje?
English: Both active substances have been available in the European Union (EU) for a number of years.
Slovenian: Obe zdravilni učinkovini sta v Evropski uniji (EU) na voljo že vrsto let.
English: Treatment should be for the shortest duration possible as long as benefits outweigh risks.
Slovenian: Zdravljenje mora trajati čim krajši čas in le, dokler so koristi večje od tveganj.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Duavive, veljavno po vsej Evropski uniji, izdala 16. decembra 2014.
English: The recommended dose of Duavive is one tablet once a day.
Slovenian: Priporočeni odmerek zdravila Duavive je ena tableta enkrat dnevno.
English: Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Slovenian: Kar zadeva varnost, dolgoročno tveganje za hiperplazijo endometrija ni bilo v celoti proučeno in CHMP je priporočil, da se izvedejo nadaljnje študije.
English: What measures are being taken to ensure the safe and effective use of Duavive?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Duavive?
English: The full EPAR and risk management plan summary for Duavive 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) in povzetek načrta obvladovanja tveganj za zdravilo Duavive sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Duavive.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Duavive.
English: What are the risks associated with Duavive?
Slovenian: Kakšna tveganja so povezana z zdravilom Duavive?
English: It is not intended to provide practical advice on how to use Duavive.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: A risk management plan has been developed to ensure that Duavive is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Duavive je bil pripravljen načrt obvladovanja tveganj.
English: Why is Duavive approved?
Slovenian: Zakaj je bilo zdravilo Duavive odobreno?
English: What is Duavive and what is it used for?
Slovenian: Kaj je zdravilo Duavive in za kaj se uporablja?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Duavive večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).
Slovenian: Najpogostejši neželeni učinek zdravila Duavive (ki lahko prizadene več kot 1 osebo od 10) je bolečina v trebuhu.
English: What benefits of Duavive have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Duavive izkazalo v študijah?
English: Duavive conjugated oestrogens / bazedoxifene
Slovenian: Duavive konjugirani estrogeni/bazedoksifen
English: Other information about Duavive
Slovenian: Druge informacije o zdravilu Duavive
English: It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).
Slovenian: Daje se ženskam, ki imajo še vedno maternico in ki jih ni mogoče zdraviti z zdravili, ki vsebujejo progestogen (zdravila, pridobljena iz hormona, imenovanega progesteron).
English: Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Slovenian: Ker so bili opaženi učinki zdravljenja manjši kot učinki alternativnih zdravljenj (z zdravili, ki vsebujejo progestogen), je CHMP zaključil, da lahko zdravilo Duavive jemljejo le ženske, ki ne smejo jemati teh drugih zdravil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Duavive in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For more information about treatment with Duavive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Duavive preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems.
Slovenian: Nekatere ženske ne smejo uporabljati zdravila Duavive, med drugim tiste, ki so imele težave zaradi venske trombembolije (krvnih strdkov v venah), kot so globoka venska tromboza, pljučna embolija (krvni strdek v pljučih) in tromboza mrežnične vene (krvni strdek v zadnjem delu očesa) ali imajo zvečano tveganje za takšne težave.
English: However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer.
Slovenian: Vendar pa lahko estrogeni, če se uporabljajo sami, povzročijo hiperplazijo (rast) endometrija (maternične sluznice), kar lahko privede do raka endometrija.
English: For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Duavive naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: An additional study also looked at the effects of Duavive on osteoporosis.
Slovenian: V dodatni študiji so proučili tudi učinke zdravila Duavive na osteoporozo.
English: The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.
Slovenian: CHMP je prav tako ugotovil, da je dolgotrajna uporaba zdravila Duavive povezana s tveganjem za kap in vensko trombembolijo, ki je podobno tveganju pri konjugiranih estrogenih in bazedoksifenu, kadar se uporabljajo ločeno.
English: Duavive is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Slovenian: Zdravilo Duavive lahko uporabljajo le ženske po menopavzi, zato ga ne smejo uporabljati ženske, ki lahko zanosijo.
English: Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area).
Slovenian: Zdravilo Duavive so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo 996 žensk po menopavzi, da bi proučili učinke na bodisi vročinske oblive bodisi vulvovaginalno atrofijo (suhost, draženje in bolečine v predelu genitalij).
English: One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy.
Slovenian: Ena od zdravilnih učinkovin zdravila Duavive, konjugirani estrogeni, deluje kot hormonsko nadomestno zdravljenje.
English: Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Slovenian: Konjugirani estrogeni so že več let na voljo kot hormonsko nadomestno zdravljenje, bazedoksifen pa je bil odobren leta 2009 kot zdravilo za osteoporozo (bolezen, ki povzroča krhkost kosti) pri ženskah po menopavzi.
English: For the full list of all side effects and restrictions with Duavive, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri zdravilu Duavive glejte navodilo za uporabo.
English: It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent.
Slovenian: Ne smejo ga uporabljati niti ženske, ki imajo ali so imele raka dojke oziroma pri katerih obstaja sum, da ga imajo; enako velja tudi za druge rake, ki so odvisni od estrogenov.
English: It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.
Slovenian: Konjugirani estrogeni nadomeščajo hormone estrogene, ki se pri ženskah po menopavzi naravno več ne tvorijo, in tako lajšajo simptome, kot so vročinski oblivi.
English: Duavive is a medicine used for the treatment of symptoms (such as hot flushes) caused by low blood levels of the female hormone oestrogen in women who have been through the menopause.
Slovenian: Zdravilo Duavive se uporablja za zdravljenje simptomov (kot so vročinski oblivi), ki jih povzročajo nizke ravni ženskega hormona estrogena v krvi žensk po menopavzi.
English: Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3.
Slovenian: Pri zdravljenju z zdravilom Duavive so zabeležili tudi večje povprečno zmanjšanje dnevne ocene resnosti vročinskih oblivov kot pri zdravljenju s placebom: 0,9 proti 0,3.
English: Duavive therefore also contains the active substance bazedoxifene, which blocks the effects of oestrogens on the womb and so reduces the risk of endometrial cancer.
Slovenian: Zdravilo Duavive zaradi tega vsebuje tudi zdravilno učinkovino bazedoksifen, ki zavira učinke estrogenov na maternico in tako zmanjšuje tveganje za raka endometrija.
English: In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo.
Slovenian: V študiji, v kateri so preučevali učinke na vročinske oblive, je zdravljenje z zdravilom Duavive (konjugirani estrogeni 0,45 mg in bazedoksifen 20 mg) v 12 tednih zmanjšalo povprečno dnevno število zmernih in hudih vročinskih oblivov za 7,6 v primerjavi s 4,9 pri placebu.
English: It must not be used in women who have had a stroke or heart attack.
Slovenian: Zdravila Duavive prav tako ne smejo uporabljati ženske, ki so preživele možgansko kap ali srčni infarkt.
English: It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.
Slovenian: Na voljo je v obliki tablet s prirejenim sproščanjem (vsebujejo 0,45 mg konjugiranih estrogenov in 20 mg bazedoksifena), iz katerih se bazedoksifen sprosti takoj, konjugirani estrogeni pa se sproščajo dlje časa.
English: Duavive contains two active substances: conjugated oestrogens and bazedoxifene.
Slovenian: Zdravilo Duavive vsebuje dve zdravilni učinkovini: konjugirane estrogene in bazedoksifen.
English: How is Duavive used?
Slovenian: Kako se zdravilo Duavive uporablja?
English: The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.
Slovenian: Študija, v kateri so proučevali učinke zdravila Duavive na vulvovaginalno atrofijo v primerjavi s placebom, je pokazala izboljšanje določenih znakov vaginalne atrofije, vendar ne najbolj motečih simptomov.
English: Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared with placebo.
Slovenian: Dokazano je bilo, da zdravilo Duavive izboljša simptome, ki jih povzroča pomanjkanje estrogena pri ženskah po menopavzi, ko so ga primerjali s placebom.
English: Duavive can only be obtained with a prescription.
Slovenian: Izdaja zdravila Duavive je le na recept.
English: Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former.
Slovenian: Ker študije s kombinacijo večje jakosti niso prepričljivo pokazale, da je ta jakost učinkovitejša kot odobrena jakost zdravila Duavive, je družba umaknila vlogo za pridobitev dovoljenja za promet za zdravilo večje jakosti.
English: Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.
Slovenian: Podobne rezultate je dalo zdravljenje s konjugiranim estrogenom večje jakosti (0,625 mg) skupaj z bazedoksifenom (20 mg), ko so ga primerjali z zdravljenjem s placebom.
English: How does Duavive work?
Slovenian: Kako zdravilo Duavive deluje?