FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 4 mg mifamurtide*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 4 mg mifamurtida*.
English: The most frequent adverse reactions are chills, pyrexia, fatigue, nausea, tachycardia and headache.
Slovenian: Najpogostejši neželeni učinki so mrzlica, zvišana telesna temperatura, utrujenost, navzea, tahikardija in glavobol.
English: Hypertension, Hypotension
Slovenian: Zelo pogosti Hipertenzija, Hipotenzija Pogosti
English: Powder for concentrate for dispersion for infusion
Slovenian: FARMACEVTSKA OBLIKA Prašek za koncentrat za disperzijo za infundiranje.
English: Using the needle and syringe, 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection should be withdrawn from the bag.
Slovenian: Z iglo in brizgo iz vrečke izvlecite 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje.
English: If you are breast-feeding, you should discuss with your doctor.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom.
English: The 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection bag, needle and syringe should be unpacked (not provided in the pack).
Slovenian: Pripravite vrečko s 100 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje ter iglo in brizgo (niso priložene).
English: Immune system disorders
Slovenian: Neželeni učinki Organski sistem
English: After reconstitution, each mL suspension in the vial contains 0.08 mg mifamurtide.
Slovenian: Po rekonstituciji en ml suspenzije v viali vsebuje 0,08 mg mifamurtida.
English: Post-procedural pain
Slovenian: Bolečina po posegu
English: *fully synthetic analogue of a component of Mycobacterium sp. cell wall.
Slovenian: *povsem sintetični analog sestavine celične stene Mycobacterium sp. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Therefore, the SmPC of mifamurtide should be updated with the inclusion of pericardial effusion as an ADR in section 4.8 under SOC Cardiac disorders.
Slovenian: Zato je povzetek glavnih značilnosti zdravila za mifamurtid treba posodobiti tako, da se perikardialni izliv vključi med neželene učinke v poglavju 4.8 pod organski sistem srčne bolezni, z oznako »neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)«.
English: Metabolism and nutritional disorders Anorexia (21%) was very commonly reported in phase I and II studies of mifamurtide
Slovenian: faze mifamurtida so zelo pogosto poročali o anoreksiji (21%).
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Kategorija pogostnosti
English: Powder for concentrate for dispersion for infusion 4 mg mifamurtide
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za disperzijo za infundiranje 4 mg mifamurtida
English: MEPACT is administered by intravenous infusion over a period of 1 hour.
Slovenian: -Zdravilo MEPACT se aplicira v obliki enourne intravenske infuzije.
English: Patient identification, time and date should be added to the label on the bag containing the reconstituted, filtered and diluted liposomal suspension.
Slovenian: Na nalepko na vrečki, ki vsebuje rekonstituirano, filtrirano in razredčeno liposomsko suspenzijo, napišite bolnikove identifikacijske podatke, čas in datum.
English: After reconstitution, each mL of suspension contains 0.08 mg of mifamurtide.
Slovenian: Po rekonstituciji en ml suspenzije vsebuje 0,08 mg mifamurtida.
English: Fever, Chills, Fatigue, Hypothermia, Pain, Malaise, Asthenia, Chest pain
Slovenian: Zelo pogosti Zvišana telesna temperatura, Mrzlica, Utrujenost, Hipotermija, Bolečina, Splošno slabo počutje, Astenija, Bolečina v prsnem košu
English: You should be more closely monitored while receiving MEPACT treatment.
Slovenian: V takšnih primerih je med zdravljenjem z zdravilom MEPACT potreben skrben zdravniški nadzor.
English: Upper abdominal pain, Dyspepsia, Abdominal distension, Lower abdominal pain
Slovenian: Bolečina v zgornjem predelu trebuha, Dispepsija, Občutek polnosti v trebuhu, Bolečina v spodnjem predelu trebuha
English: Respiratory distress
Slovenian: Dihalna stiska
English: Blurred vision
Slovenian: Zamegljen vid
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk Pogosti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA
English: Myalgia, Arthralgia, Back pain, Pain in extremity
Slovenian: Zelo pogosti Mialgija, Artralgija, Bolečina v hrbtu, Bolečina v okončinah
English: ANNEX II
Slovenian: V študiji II.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja Zelo pogosti Hiperhidroza Pogosti
English: Vomiting, Diarrhoea, Constipation, Abdominal pain, Nausea
Slovenian: Zelo pogosti Bruhanje, Driska, Zaprtost, Bolečina v trebuhu, Navzea
English: Doctors and patients must be aware of this possibility.
Slovenian: Zdravniki in bolniki se morajo zavedati te možnosti.
English: It has also been studied as part of assisted reproductive techniques in 470 women.
Slovenian: Proučevali so ga tudi kot del postopkov asistirane reprodukcije pri 470 ženskah.
English: In some women, the ovaries can over-respond to stimulation.
Slovenian: Pri nekaterih ženskah se lahko jajčniki čezmerno odzovejo na stimulacijo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for GONAL-f to Merck Serono Europe Ltd. on 20 October 1995.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom GONAL-f, veljavno po vsej Evropski uniji, odobrila družbi Merck Serono Europe Ltd dne 20. oktobra 1995.
English: After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.
Slovenian: Po prvem injiciranju si lahko bolnik sam ali s pomočjo partnerja injicira zdravilo, če sta dovolj motivirana, če sta bila za to ustrezno usposobljena in če imata na voljo strokovno svetovanje.
English: In men, the studies looked at the number of men who started to produce sperm within the first 18 months of treatment.
Slovenian: Pri moških je bilo v študijah pomembno število moških, pri katerih je v prvih 18 mesecih zdravljenja začela nastajati sperma.
English: GONAL-f follitropin alfa
Slovenian: GONAL-f folitropin alfa
English: The dose of GONAL-f and how often it is given depend on why it is being used and on the patient's response to treatment.
Slovenian: Odmerek zdravila GONAL-f in kako pogosto se daje sta odvisna od razloga za uporabo in od bolnikovega odziva na zdravljenje.
English: In the studies of women, the main measures of effectiveness were the number of eggs collected, the number of women who released eggs and the number of follicles produced in the ovaries (small sacs that hold the eggs).
Slovenian: V študijah pri ženskah je bilo glavno merilo število zbranih jajčec, število žensk, pri katerih so se jajčeca sprostila in število foliklov, proizvedenih v jajčnikih (majhne vrečice, ki držijo jajčeca).
English: Because these conditions are rare, GONAL-f was not compared with any other treatments in these studies, and the low number of patients in the studies was considered to be acceptable.
Slovenian: Ker je ta bolezen redka, zdravila GONAL-f v teh študijah niso primerjali z nobenim drugim zdravilom, majhno število bolnikov, ki je sodelovalo v študiji, pa se je zdelo sprejemljivo.
English: Previously, the FSH used in medicines was extracted from urine.
Slovenian: V preteklosti so FSH, uporabljen v zdravilih, pridobili iz urina.
English: It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons.
Slovenian: Ne sme se uporabljati, kadar se bolnik ne more učinkovito odzvati na zdravljenje, kot so bolniki, katerih jajčniki ali moda ne delujejo ali pri ženskah, ki ne smejo zanositi iz zdravstvenih razlogov.
English: Treatment with GONAL-f should be carried out by a doctor who has experience in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom GONAL-f mora izvajati zdravnik, ki ima izkušnje pri zdravljenju težav s plodnostjo.
English: GONAL-f is given by injection under the skin once a day.
Slovenian: Zdravilo GONAL-f se daj z injekcijo pod kožo enkrat na dan.
English: For more information about treatment with GONAL-f, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom GONAL-f preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The most common side effects with GONAL-f (seen in more than 1 patient in 10) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Slovenian: Najpogostejši neželeni učinki zdravila GONAL-f (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (bolečina, rdečina, modrice, oteklina ali razdraženost).
English: • adult women (aged 18 years or over) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Slovenian: • pri odraslih ženskah (starejših od 18 let), ki ne proizvajajo jajčec in se ne odzivajo na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja jajčnike, da proizvajajo jajčeca);
English: Other information about GONAL-f:
Slovenian: Druge informacije o zdravilu GONAL-f:
English: This document is a summary of the European public assessment report (EPAR) for GONAL-f.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo GONAL-f.
English: • adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Slovenian: • pri odraslih moških, ki imajo hipogonadotropni hipogonadizem (redko bolezen pomanjkanja hormona).
English: This is called ‘ovarian hyperstimulation syndrome'.
Slovenian: To imenujemo sindrom hiperstimulacije jajčnikov.
English: If the powder is being used, it should be mixed with the solvent provided just before use.
Slovenian: Če se uporablja prašek, ga je treba tik pred dajanjem zmešati s priloženim vehiklom.
English: The CHMP decided that GONAL-f's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila GONAL-f večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Slovenian: Na voljo je v obliki raztopine za injiciranje v napolnjenem peresniku ter kot prašek in vehikel, ki se zmešata v raztopino za injiciranje.
English: GONAL-f should not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Slovenian: Zdravila GONAL-f ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) folitropin alfa, FSH ali katero koli drugo sestavino zdravila.
English: What benefit has GONAL-f shown during the studies?
Slovenian: Kakšne koristi je zdravilo GONAL-f izkazalo med študijami?
English: GONAL-f, in combination with LH, has also been studied in 38 women with severe LH and FSH deficiency, and in combination with hCG in 19 men with hypogonadotrophic hypogonadism.
Slovenian: Zdravilo GONAL-f so v kombinaciji z LH proučevali tudi pri 38 ženskah s hudim pomanjkanjem LH in FSH ter v kombinaciji s hCG pri 19 moških s hipogonadotropnim hipogonadizmom.
English: GONAL-f has been studied in 222 women who do not produce eggs or respond to clomiphene citrate.
Slovenian: Zdravilo GONAL-f je bilo proučevano pri 222 ženskah, ki ne proizvajajo jajčec ali se ne odzivajo na klomifen citrat.
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 GONAL-f.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo GONAL-f, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe
English: It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Slovenian: Ne sme se uporabljati pri bolnikih s tumorji hipofize ali hipotalamusa ali rakom na prsih, maternici ali jajčnikih.
English: GONAL-f is given to stimulate the ovaries to produce more than one egg at a time;
Slovenian: Zdravilo GONAL-f se daje za spodbujanje jajčnikov k izdelavi več kot enega jajčeca naenkrat;
English: GONAL-f is used to treat the following groups:
Slovenian: Zdravilo GONAL-f se uporablja pri naslednjih skupinah bolnikov:
English: • adult women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Slovenian: • pri odraslih ženskah s hudim pomanjkanjem (zelo nizkimi ravnmi) luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH).
English: • adult women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation.
Slovenian: • pri odraslih ženskah, ki se zdravijo s postopki asistirane reprodukcije, kot je in vitro oploditev (zdravljenje neplodnosti).
English: In these studies, GONAL-f was compared with human FSH that had been extracted from urine.
Slovenian: V teh študijah so zdravilo GONAL-f primerjali s FSH, ki je bil izločen iz urina.
English: The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH.
Slovenian: Zdravilna učinkovina zdravila GONAL-f, folitropin alfa, je kopija naravnega hormona FSH.
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles.
Slovenian: Hormon FSH v telesu nadzoruje funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških pa nastajanje semenčic v modih.
English: What is the risk associated with GONAL-f?
Slovenian: Kakšna tveganja so povezana z zdravilom GONAL-f?
English: GONAL-f is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.
Slovenian: Zdravilo GONAL-f se uporablja skupaj s humanim horionskim gonadotropinom (hCG) za spodbujanje nastanka sperme.
English: GONAL-f is a medicine that contains the active substance follitropin alfa.
Slovenian: GONAL-f je zdravilo, ki vsebuje zdravilno učinkovino folitropin alfa.
English: For the full list of all side effects reported with GONAL-f, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila GONAL-f, glejte navodilo za uporabo.
English: GONAL-f was effective in triggering egg development in women with severe LH and FSH deficiency.
Slovenian: Zdravilo GONAL-f je bilo učinkovito tudi pri sprožitvi nastajanja jajčec pri ženskah s hudim pomanjkanjem LH/FSH.
English: In the study in men, GONAL-f, used in combination with hCG, was effective in stimulating sperm production, with 63% of the men starting to produce sperm.
Slovenian: V študiji pri moških je bilo zdravilo GONAL-f v kombinaciji s hCG pri 63 % moških učinkovito pri spodbujanju nastajanja sperme.
English: GONAL-f was also as effective as human FSH at stimulating the ovaries during assisted reproductive techniques.
Slovenian: Zdravilo GONAL-f je bilo enako učinkovito kot humani FSH pri spodbujanju jajčnikov med postopki asistirane reprodukcije.
English: Why has GONAL-f been approved?
Slovenian: Zakaj je bilo zdravilo GONAL-f odobreno?
English: In women, GONAL-f must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Slovenian: Pri ženskah se ne sme uporabljati ob povečanih jajčnikih ali prisotnosti cist, ki niso posledica policističnega obolenja jajčnikov, ali pri nepojasnjenem krvavenju iz nožnice.
English: GONAL-f is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
Slovenian: Zdravilo GONAL-f se daje skupaj z zdravili, ki vsebujejo LH, kar spodbudi jajčeca, da dozorijo v jajčnikih;
English: In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Slovenian: Pri več kot 1 ženski od 10 je bilo opaziti tudi nastanek ovarijskih cist (vrečic s tekočino v jajčnikih) in glavobol.
English: The full EPAR for GONAL-f can be found here.
Slovenian: Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo GONAL-f je na voljo tukaj.
English: What is GONAL-f used for?
Slovenian: Za kaj se zdravilo GONAL-f uporablja?
English: What is GONAL-f?
Slovenian: Kaj je zdravilo GONAL-f?
English: The follitropin alfa in GONAL-f is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Slovenian: Folitropin alfa v zdravilu GONAL-f je izdelan z metodo, imenovano „tehnologija rekombinantne DNK“.
English: GONAL-f was as effective as human FSH in women who did not produce eggs or respond to clomiphene citrate: 84% of the women receiving GONAL-f produced eggs, compared with 91% of those receiving human FSH.
Slovenian: Jajčeca so začela nastajati pri 84 % žensk, ki so prejemale zdravilo GONAL-f, v primerjavi z 91 % tistih, ki so prejemale humani FSH.
English: How has GONAL-f been studied?
Slovenian: Kako je bilo zdravilo GONAL-f raziskano?
English: How is GONAL-f used?
Slovenian: Kako se zdravilo GONAL-f uporablja?
English: How does GONAL-f work?
Slovenian: Kako zdravilo GONAL-f deluje?
English: The dose is adjusted to give the best control.
Slovenian: Odmerek se prilagodi tako, da se doseže najboljši možni nadzor.
English: It is available as round tablets (blue: 0.5 mg; yellow: 1 mg; peach: 2 mg).
Slovenian: Na voljo je v obliki okroglih tablet (modre barve: 0,5 mg; rumene barve: 1 mg; breskove barve: 2 mg).
English: Repaglinide Teva repaglinide EPAR summary for the public
Slovenian: Repaglinid Teva repaglinid Povzetek EPAR za javnost
English: Repaglinide Teva is taken before meals, normally up to 15 minutes before each main meal.
Slovenian: Zdravilo Repaglinid Teva se jemlje pred obroki, ponavadi največ 15 minut pred vsakim glavnim obrokom.
English: This means that Repaglinide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.
English: Other information about Repaglinide Teva:
Slovenian: Druge informacije o zdravilu Repaglinid Teva:
English: If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Slovenian: Pri bolnikih, ki preidejo z drugega zdravila za sladkorno bolezen, je priporočeni začetni odmerek 1 mg.
English: What are the benefit and risk of Repaglinide Teva?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Repaglinid Teva?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Repaglinide Teva has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Repaglinid Teva primerljivo raven kakovosti kot zdravilo NovoNorm ter da mu je biološko enakovredno.
English: Repaglinide Teva is a ‘generic medicine'.
Slovenian: Repaglinid Teva je „generično zdravilo“.
English: Because Repaglinide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je Repaglinid Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da ima enake koristi in tveganja kot referenčno zdravilo.
English: Repaglinide Teva is a medicine that contains the active substance repaglinide.
Slovenian: Repaglinid Teva je zdravilo, ki vsebuje zdravilno učinkovino repaglinid.
English: The Committee recommended that Repaglinide Teva be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Repaglinid Teva odobri dovoljenje za promet.
English: A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Slovenian: Raven bolnikove glukoze v krvi mora zdravnik redno preverjati, da določi najmanjši učinkoviti odmerek.
English: Because Repaglinide Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (this means that the two medicines produce the same levels of the active substance in the body).
Slovenian: Ker je zdravilo Repaglinid Teva generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu (tj. da zdravili dosegata enake ravni zdravilne učinkovine v telesu).
English: Therefore, the CHMP's view was that, as for NovoNorm, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu NovoNorm, odtehtajo znana tveganja.
English: Repaglinide Teva is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Slovenian: Zdravilo Repaglinid Teva se uporablja pri bolnikih s sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki ni odvisna od insulina).
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali pri kateri telo insulina ne more učinkovito izrabljati.
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Slovenian: Uporablja se skupaj z dieto in telesno dejavnostjo za znižanje glukoze (sladkorja) v krvi pri bolnikih, pri katerih hiperglikemije (visoke koncentracije glukoze v krvi) ni več mogoče nadzorovati z dieto, zmanjšanjem telesne mase in telesno dejavnostjo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Teva to Teva Pharma B.V. on 29 June 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Repaglinid Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma B.V.
English: Repaglinide Teva can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Slovenian: Zdravilo Repaglinid Teva se lahko uporabi tudi pri bolnikih s sladkorno boleznijo tipa 2, pri katerih so ravni glukoze v krvi ponavadi dobro nadzorovane z dieto, vendar doživljajo obdobja prehodne izgube nadzora.
English: Why has Repaglinide Teva been approved?
Slovenian: Zakaj je bilo zdravilo Repaglinid Teva odobreno?
English: Repaglinide Teva helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Slovenian: Zdravilo Repaglinid Teva spodbuja trebušno slinavko, da v času obrokov tvori več insulina, zato se uporablja za nadzor sladkorne bolezni tipa 2.
English: Repaglinide Teva may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Slovenian: Zdravilo Repaglinid Teva se lahko uporabi tudi z metforminom (drugim zdravilom za sladkorno bolezen) pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ne moremo zadovoljivo nadzorovati ravni glukoze v krvi.
English: The full EPAR for Repaglinide Teva can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Repaglinide Teva je na voljo tukaj.
English: How has Repaglinide Teva been studied?
Slovenian: Kako je bilo zdravilo Repaglinid Teva raziskano?