FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were also given rapid-acting insulin at mealtimes.
Slovenian: Bolniki so prejemali tudi hitrodelujoči insulin, ki se daje med obroki.
English: In type 1 diabetes, Tresiba must always be used in combination with rapid acting insulin, which is injected at mealtimes.
Slovenian: Pri sladkorni bolezni tipa 1 je treba zdravilo Tresiba vedno uporabljati v kombinaciji s hitrodelujočim insulinom, ki se injicira v času obrokov.i.
English: This means that Tresiba has a long duration of action.
Slovenian: To pomeni, da je zdravilo Tresiba zdravilo z dolgotrajnim delovanjem.
English: The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in adults with type 1 and type 2 diabetes, and more effective than sitagliptin in adults with type 2 diabetes.
Slovenian: Študije so pokazale, da je bilo zdravilo Tresiba vsaj tako učinkovito kot drugi dolgodelujoči insulini pri uravnavanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 1 in 2 ter učinkovitejše od sitagliptina pri bolnikih s sladkorno boleznijo tipa 2.
English: It also noted that Tresiba reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2 diabetes.
Slovenian: Prav tako je dognal, da zdravilo Tresiba zmanjša tveganje za pojav hipoglikemije ponoči pri bolnikih s sladkorno boleznijo tipa 1 in 2.
English: Six other main studies involving 4,076 adults with type 2 diabetes compared Tresiba with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type 2 diabetes).
Slovenian: V šestih drugih študijah, v katere je bilo vključenih 4 076 odraslih bolnikov s sladkorno boleznijo tipa 2, so zdravilo Tresiba primerjali z insulinom glarginom, insulinom detemirjem ali sitagliptinom (peroralnim zdravilom za zdravljenje sladkorne bolezni tipa 2).
English: The CHMP concluded that Tresiba is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Slovenian: CHMP je zaključil, da je zdravilo Tresiba učinkovito pri uravnavanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 1 in 2.
English: In type 2 diabetes, Tresiba can be used alone or in combination with diabetes medicines given by mouth, GLP-1 receptor agonist medicines and rapid acting mealtime insulin.
Slovenian: Pri sladkorni bolezni tipa 2 se lahko zdravilo Tresiba uporablja samostojno ali v kombinaciji z drugimi peroralnimi zdravili za zdravljenje sladkorne bolezni, zdravili, ki vsebujejo spodbujevalce receptorjev GLP-1, in hitrodelujočim insulinom, ki se daje v času obrokov.
English: How has Tresiba been studied?
Slovenian: Kako je bilo zdravilo Tresiba raziskano?
English: What is Tresiba used for?
Slovenian: Za kaj se zdravilo Tresiba uporablja?
English: What is Tresiba?
Slovenian: Kaj je zdravilo Tresiba?
English: How does Tresiba work?
Slovenian: Kako zdravilo Tresiba deluje?
English: How is Tresiba used?
Slovenian: Kako se zdravilo Tresiba uporablja?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sabervel on 13 April 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sabervel, veljavno po vsej Evropski uniji, odobrila dne 13. aprila 2012.
English: The full EPAR for Sabervel 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 Sabervel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The usual recommended dose of Sabervel is 150 mg once a day.
Slovenian: Običajni priporočeni odmerek zdravila Sabervel znaša 150 mg enkrat dnevno.
English: What are the benefits and risks of Sabervel?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Sabervel?
English: For more information about treatment with Sabervel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sabervel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This means that Sabervel is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aprovel.
English: Sabervel is used in adults who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Sabervel se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
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 Sabervel.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sabervel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Sabervel is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Sabervel generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Other information about Sabervel
Slovenian: Druge informacije o zdravilu Sabervel:
English: The active substance in Sabervel, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina zdravila Sabervel, irbesartan, je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu prepreči delovanje hormona, imenovanega angiotenzin II.
English: This is a summary of the European public assessment report (EPAR) for Sabervel.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sabervel.
English: Sabervel is a ‘generic medicine'.
Slovenian: Zdravilo Sabervel je „generično zdravilo“.
English: The Committee recommended that Sabervel be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Sabervel odobri dovoljenje za promet.
English: Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da koristi, tako kot pri zdravilu Aprovel, odtehtajo znana tveganja.
English: Sabervel is a medicine that contains the active substance irbesartan.
Slovenian: Sabervel je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
English: Because Sabervel is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel.
Slovenian: Ker je zdravilo Sabervel generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Aprovel.
English: The CHMP concluded that, in accordance with EU requirements, Sabervel has been shown to have comparable quality and to be bioequivalent to Aprovel.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sabervel primerljivo raven kakovosti kot zdravilo Aprovel ter da mu je biološko enakovredno.
English: Why has Sabervel been approved?
Slovenian: Zakaj je bilo zdravilo Sabervel odobreno?
English: Sabervel is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Slovenian: Zdravilo Sabervel se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2.
English: In patients with hypertension and type 2 diabetes, Sabervel is added to other treatments for hypertension.
Slovenian: Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Sabervel uvede sočasno z drugimi načini zdravljenja visokega krvnega tlaka.
English: How has Sabervel been studied?
Slovenian: Kako je bilo zdravilo Sabervel raziskano?
English: What is Sabervel used for?
Slovenian: Za kaj se zdravilo Sabervel uporablja?
English: How is Sabervel used?
Slovenian: Kako se zdravilo Sabervel uporablja?
English: How does Sabervel work?
Slovenian: Kako zdravilo Sabervel deluje?
English: What is Sabervel?
Slovenian: Kaj je zdravilo Sabervel?
English: You have two options:
Slovenian: Na voljo sta dve možnosti:
English: Your doctor will tell you when and how to do this.
Slovenian: Zdravnik vam bo pojasnil, kdaj in kako to storite.
English: Date of first authorisation: 19 March 2009 Date of latest renewal: 21 February 2014
Slovenian: Datum prve odobritve: 19. marec 2009 Datum zadnjega podaljšanja: 21. februar 2014
English: However, to date, no particular malformative effect has been reported.
Slovenian: Vendar do danes niso poročali o nobenih posebnih malformacijah.
English: Men with too much FSH in their blood
Slovenian: Moški, ki imajo v krvi preveč FSH
English: Clinical Efficacy and Safety
Slovenian: Klinična učinkovitost in varnost
English: Median duration of treatment (days)
Slovenian: Srednji čas trajanja zdravljenja (dni)
English: Tell your doctor immediately.
Slovenian: Nemudoma obvestite zdravnika.
English: * Differences between the 2 groups were statistically significant (p0.05).
Slovenian: * Razlike med obema skupinama so bile statistično značilne (p0,05).
English: Your doctor or nurse will tell you where to inject.
Slovenian: Zdravnik ali medicinska sestra vam bosta svetovala, kam injicirati.
English: This may be noticed as pain in the stomach.
Slovenian: To lahko zaznate v obliki bolečine v trebuhu.
English: Further details on the treatment schedule are given below.
Slovenian: Podrobnosti o režimu zdravljenja so navedene spodaj.
English: • if you, or anyone in your immediate family, have ever had a thrombosis
Slovenian: • če ste vi ali kdor koli v vaši ožji družini že kdaj imeli trombozo,
English: • have been told by a doctor that pregnancy would be dangerous for you.
Slovenian: • če vam je kakšen zdravnik kdaj rekel, da bi bila nosečnost za vas nevarna.
English: Both have an absolute bioavailability of approximately 77%.
Slovenian: Pri obeh je absolutna biološka uporabnost približno 77 %.
English: The majority of these local reactions are mild and transient in nature.
Slovenian: Te lokalne reakcije pa so večinoma blage in prehodne.
English: If you are a man:
Slovenian: Če ste moški:
English: • are pregnant or think that you may be pregnant
Slovenian: • če ste noseči ali menite, da bi lahko bili noseči,
English: See warnings and precautions in section 2.
Slovenian: Glejte opozorila in previdnostne ukrepe v poglavju 2.
English: These antibiotics may cause hypersensitivity reactions in susceptible persons.
Slovenian: Ta dva antibiotika lahko povzročita preobčutljivostne reakcije pri občutljivih osebah.
English: Empty cartridges must not be refilled.
Slovenian: Praznih vložkov ne smete ponovno polniti.
English: If you are a woman:
Slovenian: Če ste ženska:
English: Usually, 7 to 14 days of treatment are sufficient.
Slovenian: Običajno zadostuje 7 do 14 dni zdravljenja.
English: Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
Slovenian: Med pogostimi neželenimi učinki so našteti tudi tisti, o katerih so poročali samo enkrat, ker že eno poročilo pomeni pogostnost več kot 1 %.
English: Blood clots can lead to serious medical conditions, such as:
Slovenian: Krvni strdki lahko povzročijo resna bolezenska stanja, na primer:
English:  Contact your doctor.
Slovenian:  Obvestite zdravnika.
English: This increase enables therapeutic FSH concentrations to be reached.
Slovenian: To povečanje omogoča terapevtske koncentracije FSH.
English: Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration.
Slovenian: Zaradi tveganja za pojav OHSS je treba bolnice spremljati vsaj dva tedna po uporabi hCG.
English: Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy.
Slovenian: Pozni OHSS se pojavi več kot 10 dni po uporabi hCG kot posledica hormonskih sprememb, povezanih z nosečnostjo.
English: Clinical experience with Fertavid is based on up to three treatment cycles in both indications.
Slovenian: Klinične izkušnje z zdravilom Fertavid temeljijo na treh ciklusih zdravljenja za obe indikaciji.
English: You should not use Fertavid if you are already pregnant, or think you might be pregnant.
Slovenian: Zdravila Fertavid ne smete uporabljati, če ste noseči ali menite, da bi lahko bili noseči.
English: In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for six to twelve days are sufficient, although longer treatment may be necessary.
Slovenian: Klinične študije so pokazale, da zadostujejo vzdrževalni odmerki od 75 do 375 i.e., ki jih dajte ženski od šest do dvanajst dni, čeprav je lahko potrebno tudi daljše zdravljenje.
English: If the needle position is correct the plunger should be quite difficult to draw back.
Slovenian: Če je položaj igle pravilen, je bat precej težko izvleči.
English: Step 5 - Checking the correct needle position
Slovenian: Peti korak - preverjanje pravilnega položaja igle
English: It is possible to inject in other areas.
Slovenian: Možno je tudi injiciranje na druga mesta.
English: Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of Fertavid from day to day.
Slovenian: Zdravnik bo redno preverjal učinke zdravljenja, da bo lahko izbral pravilen odmerek zdravila Fertavid za vsak dan posebej.
English: If you are troubled by stomach pains, tell your doctor immediately.
Slovenian: Če imate težave zaradi bolečin v trebuhu, morate to nemudoma povedati zdravniku.
English: • a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.
Slovenian: • nezadosten dotok krvi (globoko vensko trombozo), ki lahko povzroči izgubo roke ali noge.
English: This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries are overly stimulated and the growing follicles become larger than normal.
Slovenian: To je zelo pomembno, ker lahko prevelik odmerek FSH povzroči redek, toda resen zaplet, pri katerem je stimulacija jajčnikov prevelika in rastoči folikli postanejo večji, kot je normalno.
English: • have any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).
Slovenian: • če imate kakšno drugo bolezensko stanje (na primer sladkorno bolezen, srčno bolezen ali katero drugo kronično bolezen).
English: Make a note of when you start storing the product out of the refrigerator.
Slovenian: Zabeležite si, kdaj ste vzeli zdravilo iz hladilnika.
English: • Women who are not ovulating A starting dose is set by your doctor.
Slovenian: • Ženske, ki nimajo ovulacije Začetni odmerek določi zdravnik.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Ker študije kompatibilnosti niso bile izvedene, zdravila ne smemo mešati z drugimi zdravili.
English: FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
Slovenian: FSH spada v skupino gonadotropinov, ki imajo pomembno vlogo pri človekovi plodnosti in razmnoževanju.
English: If OHSS develops, standard and appropriate management of OHSS should be implemented and followed.
Slovenian: Če se pojavi OHSS, je treba uvesti in upoštevati standardno in ustrezno obravnavo OHSS.
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; ATC code: G03G A06.
Slovenian: Farmakoterapevtska skupina: spolni hormoni in modulatorji genitalnega sistema, gonadotropni hormoni; oznaka ATC: G03GA06.
English: Clinical use of Fertavid by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated).
Slovenian: Klinična uporaba zdravila Fertavid intramuskularno ali subkutano lahko povzroči lokalne reakcije na mestu injiciranja (pri 3 % vseh zdravljenih bolnikov).
English: The best site for an injection under the skin is in the lower stomach around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Slovenian: Najbolj primerno mesto za podkožno injekcijo je spodnji del trebuha okoli popka (e), kjer je veliko ohlapne kože in plasti maščobnega tkiva.
English: Fertavid is usually not effective in such cases.
Slovenian: V takih primerih zdravilo Fertavid običajno ni učinkovito.
English: With the other hand, insert the needle at an angle of 90 degrees into the skin's surface, as shown in the picture (f).
Slovenian: Z drugo roko vbodite iglo v kožo pod kotom 90 stopinj, kakor je prikazano na sliki (f).
English: Especially when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a dose being given.
Slovenian: Še posebej pri prehodu z brizge na peresnik so lahko potrebne manjše prilagoditve odmerka, da preprečimo dajanje prevelikega odmerka.
English: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss The Netherlands
Slovenian: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss Nizozemska
English: Additionally for females
Slovenian: Dodatno za ženske
English: How are the injections given
Slovenian: Kako dajemo injekcije
English: Treatment of females:
Slovenian: Zdravljenje žensk:
English: Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).
Slovenian: Občasno so opažali generalizirane preobčutljivostne reakcije (pri približno 0,2 % vseh bolnikov, zdravljenih s folitropinom beta).
English: For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended.
Slovenian: Ženske, ki dobijo prvi ciklus stimulacije jajčnikov in za katere so dejavniki tveganja le delno znani, je priporočljivo natančno opazovati glede zgodnjih znakov in simptomov OHSS.
English: The risk can be reduced by careful monitoring of follicular development during treatment.
Slovenian: To tveganje je mogoče zmanjšati s skrbnim spremljanjem razvoja foliklov med zdravljenjem.
English: Start again with Step 1 using a new syringe, new needles and a new vial of Fertavid.
Slovenian: Potem spet začnite s prvim korakom, pri tem pa uporabite novo brizgo, nove igle in novo vialo zdravila Fertavid.
English: A daily increase of oestradiol levels of 40-100% is considered to be optimal.
Slovenian: 40-100 % dnevno povečanje plazemske koncentracije estradiola šteje za optimalnega.
English: Median total dose (IU)
Slovenian: Srednji celotni odmerek (i.e.)
English: If your sperm production has not started after this period, your treatment may carry on for at least 18 months.
Slovenian: Če po tem času ne bo začela nastajati sperma, se bo zdravljenje lahko nadaljevalo vsaj 18 mesecev.
English: If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e. more than a daily doubling for oestradiol for two or three consecutive days, the daily dose should be decreased.
Slovenian: Če je število primernih foliklov preveliko ali če plazemske vrednosti estradiola prehitro naraščajo, tj. na več kot dvakratno vrednost estradiola dva ali tri dni zapored, je treba dnevni odmerek zmanjšati.
English: • have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
Slovenian: • če ste imeli kdaj v preteklosti alergijsko reakcijo na določene antibiotike (neomicin in/ali streptomicin),
English: Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation.
Slovenian: Zgodnji OHSS se po navadi pojavi v 10 dneh po uporabi hCG in je lahko povezan s čezmernim odzivom jajčnikov na stimulacijo z gonadotropinom.
English: Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics, genetic background of both parents) may be associated with an increased risk of birth defects.
Slovenian: Poleg tega so lahko večplodna nosečnost in značilnosti bolnikov, ki se zdravijo zaradi neplodnosti (npr. starost ženske, značilnosti sperme, genetske značilnosti obeh staršev) povezane z večjim tveganjem za prirojene napake.
English: Draw the solution up into the syringe (b), and replace the needle with an injection needle (c).
Slovenian: Posesajte raztopino v brizgo (b) in zamenjajte iglo z injekcijsko iglo (c).
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Fertavid induced no toxicologically significant effects.
Slovenian: V študijah s ponavljajočimi se odmerki pri podganah (dvotedenskih) in psih (13-tedenskih) z odmerki, ki so bili 100-krat večji od največjega odmerka za človeka, zdravilo Fertavid ni povzročilo nobenih pomembnih toksikoloških učinkov.
English: Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.
Slovenian: Večplodna nosečnost pomeni večjo zdravstveno ogroženost tako matere kot otrok v času okoli poroda.
English: It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.
Slovenian: Vendar je treba ob tem upoštevati, da tudi sama nosečnost poveča tveganje za trombozo.
English: In adult females: Fertavid is indicated for the treatment of female infertility in the following clinical situations:
Slovenian: Pri odraslih ženskah: Zdravilo Fertavid je indicirano za zdravljenje neplodnosti pri ženskah v naslednjih kliničnih primerih:
English: There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients.
Slovenian: Med ženskami obstajajo velike razlike v odzivanju jajčnikov na zdravljenje s FSH, zaradi česar ni mogoče predpisati režima odmerjanja, ki bi bil primeren za vse ženske.
English: Depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Slovenian: Bat potiskajte počasi in enakomerno, tako da boste raztopino pravilno injicirali in ne boste poškodovali kožnega tkiva.
English: This may be of particular relevance when switching between the pen injector and a conventional syringe within one treatment cycle.
Slovenian: To je lahko še posebej pomembno pri prehodu z navadne brizge na peresnik v času enega ciklusa terapije.
English: Due to the sustained release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours.
Slovenian: Zaradi upočasnjenega sproščanja z mesta injiciranja in zaradi razpolovnega časa izločanja, ki je okoli 40 ur (od 12 do 70 ur), ostanejo vrednosti FSH povečane 24 do 48 ur.
English: See also section 4 on possible side effects.
Slovenian: Preberite tudi poglavje 4, Možni neželeni učinki.
English: In adult males: • Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Slovenian: Pri odraslih moških: • Nezadostna spermatogeneza zaradi hipogonadotropnega hipogonadizma.
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Slovenian: Celotne izkušnje z zunajtelesno oploditvijo kažejo, da uspešnost zdravljenja ostaja na splošno nespremenjena med prvimi štirimi poskusi, nato pa počasi pada.
English: A starting dose of 100-225 IU is recommended for at least the first four days.
Slovenian: Priporočamo začetni odmerek 100 do 225 i.e., ki ga dajte ženski najmanj prve štiri dni.
English: The use of Fertavid during pregnancy is not indicated.
Slovenian: Uporaba zdravila Fertavid med nosečnostjo ni indicirana.