FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaemia symptoms and sequelae may vary with age, gender and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Slovenian: Simptomi anemije in posledična bolezenska stanja se lahko spreminjajo glede na starost, spol in skupno bolezensko breme.
English: Silapo may be given during the dialysis session or after you have received a dialysis session.
Slovenian: Zdravilo Silapo se lahko daje med dializo ali pa po njej.
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Slovenian: Simptomi anemije in posledična bolezenska stanja se lahko spreminjajo glede na starost, spol in skupno breme bolezni.
English: Silapo should be withheld when the haemoglobin concentration exceeds 12 g/dl (7.5 mmol/l).
Slovenian: Začasna prekinitev odmerjanja in zmanjšanje odmerka Zdravljenje z Silapo je treba prekiniti, kadar koncentracija hemoglobina preseže 12 g/dl (7,5 mmol/).
English: Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection)
Slovenian: Menjava med injiciranjem v žilo in pod kožo (med intravenskim in subkutanim injiciranjem) Ko bo Vaše stanje pod nadzorom, boste začeli dobivati običajne odmerke zdravila Silapo.
English: This summary was last updated in 05-2015.
Slovenian: Povzetek je bil nazadnje posodobljen 05-2015.
English: Increlex mecasermin
Slovenian: Increlex mekasermin
English: Because the disease is rare, many of the children were included in more than one of the studies.
Slovenian: Ker je bolezen redka, je bilo več otrok vključenih v več kot eno študijo.
English: The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.
Slovenian: Študije so trajale od 15 mesecev do osem let, glavno merilo učinkovitosti pa je bila hitrost rasti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Increlex on 3 August 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Increlex, veljavno po vsej Evropski uniji, izdala 3. avgusta 2007.
English: Increlex has been authorised under ‘Exceptional Circumstances'.
Slovenian: Zdravilo Increlex je bilo odobreno „v izjemnih okoliščinah“.
English: The injection should be carried out shortly before or after a meal or snack.
Slovenian: Injekcijo je treba dati neposredno pred obrokom oziroma prigrizkom ali po njem.
English: It should never be injected into a vein.
Slovenian: Zdravilo se ne sme nikoli injicirati v žilo.
English: European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove informacije in posodobila ta povzetek, če bo to potrebno.
English: For more information, see the summary of product characteristics.
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila.
English: IGF-1 is important in determining how tall a child grows.
Slovenian: IGF-1 ima zelo pomemben vpliv na to, do kakšne višine bo otrok zrasel.
English: What measures are being taken to ensure the safe and effective use of Increlex?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Increlex?
English: It does this by stimulating cells to divide and grow and to absorb nutrients, supporting the growth of body tissues.
Slovenian: Ta hormon spodbuja celice, da se delijo in rastejo ter vsrkavajo hranilne snovi, kar pospešuje rast telesnih tkiv.
English: The maximum dose is 0.12 mg per kilogram twice a day.
Slovenian: Največji dovoljeni odmerek je 0,12 mg na kilogram dvakrat dnevno.
English: When the results of the studies were looked at together, the average growth rate was 2.8 cm per year before treatment.
Slovenian: Ob upoštevanju skupnih rezultatov študij je bila povprečna stopnja rasti pred zdravljenjem 2,8 cm na leto.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Increlex.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Increlex.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Increlex.
English: Treatment should be interrupted if the patient cannot eat for any reason.
Slovenian: Če bolnik iz kakršnega koli razloga ne more jesti, je treba zdravljenje prekiniti.
English: Some of the studies also included children who had defects in the gene for growth hormone (GH) and who had developed antibodies against GH.
Slovenian: Nekatere študije so vključevale tudi otroke s poškodovanim genom za rastni hormon (GH), ki so proti njemu razvili protitelesa.
English: Increlex has been studied in five studies involving a total of 76 children aged between one and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
Slovenian: Zdravilo Increlex so proučevali v petih študijah, v katerih je sodelovalo skupno 76 otrok, starih od enega do 15 let, s hudim primarnim pomanjkanjem IGF-1, pri čemer jih je devet pred vključitvijo v te študije prejemalo drugo vrsto rekombinantnega IGF-1.
English: The company that makes Increlex will carry out a long-term study looking at the safety of the medicine, when treatment is started in young children and continued into adulthood.
Slovenian: Družba, ki proizvaja zdravilo Increlex, bo izvedla dolgoročno raziskavo o varnosti zdravila v primeru, ko se zdravljenje začne pri majhnih otrocih in nadaljuje v obdobju odraslosti.
English: The company applied for an authorisation to use Increlex in these children, but withdrew its application after the end of the medicine's assessment, as this disease is not listed in the medicine's ‘orphan' designation.
Slovenian: Družba je zaprosila za dovoljenje za uporabo zdravila Increlex pri teh otrocih, vendar je ob zaključku ocenjevanja zdravila umaknila vlogo, saj ta bolezen ni navedena v določitvi zdravila kot zdravila sirote.
English: The dose should be tailored for each patient according to the speed of growth and side effects.
Slovenian: Odmerek je treba prilagoditi vsakemu posameznemu bolniku glede na hitrost rasti in neželene učinke.
English: The company will also supply dose calculators to help doctors and patients (or their carers) to work out the appropriate dose.
Slovenian: Priskrbela bo tudi računala za izračun odmerkov, ki bodo v pomoč zdravnikom in bolnikom (ali njihovim skrbnikom) pri določanju ustreznega odmerka.
English: Patients with this condition have low levels of the hormone insulin-like growth factor-1 or IGF-1, which is required for normal growth.
Slovenian: Takšni bolniki imajo zelo nizke ravni hormona, imenovanega insulinu podoben rastni faktor-1 ali IGF-1, ki je potreben za normalno rast.
English: The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Slovenian: Priporočeni začetni odmerek znaša 0,04 mg na kilogram telesne mase dvakrat dnevno.
English: For more information about treatment with Increlex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Increlex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP decided that Increlex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Increlex večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Increlex works in the same way as natural IGF-1, replacing the missing hormone and helping the child to grow taller.
Slovenian: Zdravilo Increlex deluje enako kot naravni IGF-1 ter tako nadomešča manjkajoči hormon in pomaga otrokom pri rasti.
English: The most common side effects with Increlex (seen in more than 1 patient in 10) are headache, hypoglycaemia (low blood sugar levels), vomiting (being sick), injection site hypertrophy (lumps at the site of injection) and otitis media (infection of the middle ear).
Slovenian: Najpogostejši neželeni učinki zdravila Increlex (opaženi pri več kot 1 od 10 bolnikov) so glavobol, hipoglikemija (nizka raven sladkorja v krvi), bruhanje, hipertrofija na mestu injiciranja (zatrdline na mestu injiciranja) in otitis media (vnetje srednjega ušesa).
English: Other information about Increlex
Slovenian: Druge informacije o zdravilu Increlex
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Increlex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Increlex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Increlex must not be used in premature babies or newborns.
Slovenian: Zdravilo se ne sme uporabljati pri nedonošenčkih ali novorojenčkih.
English: Treatment with Increlex should be supervised by doctors who have experience in the diagnosis and treatment of patients with growth disorders.
Slovenian: Zdravljenje z zdravilom Increlex mora nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov z motnjami rasti.
English: A risk management plan has been developed to ensure that Increlex is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Increlex je bil pripravljen načrt obvladovanja tveganj.
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 Increlex.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Increlex must not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth).
Slovenian: Zdravila Increlex ne smejo uporabljati bolniki, ki imajo ali utegnejo imeti aktivno neoplazijo (nenormalno rast celic).
English: The active substance in Increlex, mecasermin, is a copy of the hormone IGF-1.
Slovenian: Zdravilna učinkovina zdravila Increlex, mekasermin, je kopija hormona IGF-1.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Increlex, 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 in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘rare', and Increlex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Slovenian: Ker je bolnikov s primarnim pomanjkanjem IGF-1 malo, velja ta bolezen za redko, zato je bilo zdravilo Increlex 22. maja 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The full EPAR for Increlex 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 Increlex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What benefit has Increlex shown during the studies?
Slovenian: Kakšne koristi je zdravilo Increlex izkazalo med študijami?
English: One study compared Increlex with placebo (a dummy treatment) in eight patients, but the others did not compare Increlex with any other treatments.
Slovenian: V eni študiji so primerjali zdravilo Increlex s placebom (zdravilom brez zdravilne učinkovine) pri osmih bolnikih, v drugih študijah pa zdravila Increlex niso primerjali z nobenim drugim zdravilom.
English: What is the risk associated with Increlex?
Slovenian: Kakšna tveganja so povezana z zdravilom Increlex?
English: Increlex caused the speed of growth to increase.
Slovenian: Zdravilo Increlex je pospešilo hitrost rasti.
English: Increlex is used for the long-term treatment of patients aged two to 18 years who are short for their age due to a condition known as ‘severe primary insulin-like growth factor-1 deficiency'.
Slovenian: Zdravilo Increlex se uporablja za dolgotrajno zdravljenje bolnikov, starih od dve do 18 let, ki so za svojo starost premajhni zaradi „hudega primarnega pomanjkanja insulinu podobnega rastnega faktorja-1“.
English: For the full list of all side effects and restrictions with Increlex, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Increlex glejte navodilo za uporabo.
English: This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
Slovenian: Ta se je v prvem letu zdravljenja povečala na 8,0 cm, v drugem letu pa na 5,8 cm. Od četrtega leta zdravljenja dalje se je stopnja rasti ustalila pri približno 4,7 cm na leto.
English: Increlex is a solution for injection that contains the active substance mecasermin.
Slovenian: Zdravilo Increlex je raztopina za injiciranje, ki vsebuje zdravilno učinkovino mekasermin.
English: Additionally, the company that markets Increlex will supply information packs to doctors and patients explaining how the medicine is used and its side effects.
Slovenian: Poleg tega bo družba, ki izdeluje zdravilo Increlex, za zdravnike in bolnike pripravila informativne brošure z razlago uporabe zdravila in njegovih neželenih učinkov.
English: What information is still awaited for Increlex?
Slovenian: Katere informacije o zdravilu Increlex še pričakujemo?
English: Why has Increlex been approved?
Slovenian: Zakaj je bilo zdravilo Increlex odobreno?
English: Increlex is given by injection under the skin, and the injection site should be changed with each injection.
Slovenian: Zdravilo Increlex se daje z injekcijo v podkožje, pri čemer je treba za vsako naslednjo injekcijo izbrati drugo mesto injiciranja.
English: Treatment with Increlex should be stopped if neoplasia develops.
Slovenian: Če se pojavi neoplazija, je treba zdravljenje z zdravilom Increlex ustaviti.
English: How has Increlex been studied?
Slovenian: Kako je bilo zdravilo Increlex raziskano?
English: How is Increlex used?
Slovenian: Kako se zdravilo Increlex uporablja?
English: What is Increlex used for?
Slovenian: Za kaj se zdravilo Increlex uporablja?
English: How does Increlex work?
Slovenian: Kako zdravilo Increlex deluje?
English: This overview was last updated in 08-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2019.
English: Further information on Forxiga can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Forxiga.
Slovenian: Nadaljnje informacije o zdravilu Forxiga so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Forxiga.
English: What measures are being taken to ensure the safe and effective use of Forxiga?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Forxiga?
English: Forxiga received a marketing authorisation valid throughout the EU on 11 November 2012.
Slovenian: Za zdravilo Forxiga je bilo 11. novembra 2012 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: An overview of Forxiga and why it is authorised in the EU
Slovenian: Pregled zdravila Forxiga in zakaj je odobreno v EU
English: As for all medicines, data on the use of Forxiga are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Forxiga stalno spremljajo.
English: Other information about Forxiga
Slovenian: Druge informacije o zdravilu Forxiga
English: It can also be used as ‘add-on' treatment to other diabetes medicines.
Slovenian: Prav tako se lahko uporablja kot dodatek drugim zdravilom za zdravljenje sladkorne bolezni.
English: What benefits of Forxiga have been shown in studies?
Slovenian: Kakšne koristi zdravila Forxiga so se pokazale v študijah?
English: The Agency concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.
Slovenian: Agencija je zaključila, da so koristi zdravila Forxiga večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: Why is Forxiga authorised in the EU?
Slovenian: Zakaj je zdravilo Forxiga odobreno v EU?
English: Side effects reported with Forxiga are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Forxiga, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Both combinations reduced HbA1c levels by 0.52 percentage points after 52 weeks.
Slovenian: Pri obeh kombinacijah so se ravni HbA1c po 52 tednih znižale za 0,52 odstotnih točk.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forxiga have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Forxiga upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Forxiga, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Forxiga glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Forxiga is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Forxiga je na voljo v obliki tablet (5 in 10 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: The dose is 5 mg once a day and the medicine should be used with precautions to prevent diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Slovenian: Odmerek znaša 5 mg enkrat na dan, zdravilo pa je treba jemati previdno, da se prepreči diabetična ketoacidoza (resen zaplet pri sladkorni bolezni z visokimi ravnmi ketonov v krvi).
English: What is Forxiga and what is it used for?
Slovenian: Kaj je zdravilo Forxiga in za kaj se uporablja?
English: What are the risks associated with Forxiga?
Slovenian: Kakšna tveganja so povezana z zdravilom Forxiga?
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Slovenian: Glavno merilo učinkovitosti je bila raven glikoziliranega hemoglobina (HbA1c), ki kaže, kako dobro je raven glukoze v krvi uravnana.
English: For type 2 diabetes, the dose of Forxiga is 10 mg once a day.
Slovenian: Pri sladkorni bolezni tipa 2 se vzame odmerek zdravila v jakosti 10 mg enkrat na dan.
English: The company that markets Forxiga will provide information on precautions to prevent diabetic ketoacidosis in patients with type 1 diabetes, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Slovenian: Podjetje, ki trži zdravilo Forxiga, bo zagotovilo informacije o previdnostnih ukrepih za preprečevanje diabetične ketoacidoze pri bolnikih s sladkorno boleznijo tipa 1, vključno z opozorilno kartico za bolnike in priročnikom za bolnike in njihove negovalce, ter navodila za zdravstvene delavce, vključno s kontrolnim seznamom za zdravnike, ki bodo predpisovali to zdravilo.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Slovenian: V dolgoročni študiji, v katero je bilo vključenih več kot 17 000 bolnikov s sladkorno boleznijo tipa 2, so proučevali učinke dapagliflozina na kardiovaskularne bolezni (bolezni srca in ožilja).
English: Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough.
Slovenian: Forxiga je zdravilo za zdravljenje sladkorne bolezni pri odraslih, pri katerih bolezen ni zadostno urejena.
English: Forxiga was found effective in several studies in patients with type 2 and type 1 diabetes.
Slovenian: Zdravilo Forxiga se je izkazalo za učinkovito v več študijah z bolniki s sladkorno boleznijo tipa 2 in tipa 1.
English: Precautions have been recommended to reduce the risk of diabetic ketoacidosis and the Agency has asked for further studies to determine its frequency in patients with type 1 diabetes treated with Forxiga.
Slovenian: Priporočeni so bili previdnostni ukrepi za zmanjšanje tveganja diabetične ketoacidoze, agencija pa je zaprosila za nadaljnje študije, da bi ugotovila njeno pogostnost pri bolnikih s sladkorno boleznijo tipa 1, ki so bili zdravljeni z zdravilom Forxiga.
English: The most common side effect in patients with type 1 diabetes (which may affect up to 1 in 10 people) is genital infection, especially in women and a common side effect (which may affect up to 1 in 100 people) is diabetic ketoacidosis.
Slovenian: Najpogostejši neželeni učinek pri bolnikih s sladkorno boleznijo tipa 1 (ki se lahko pojavi pri največ 1 bolniku od 10) so okužbe spolovil, zlasti pri ženskah, pogost neželeni učinek (ki se lahko pojavi pri največ 1 bolniku od 100) pa je diabetična ketoacidoza.
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Slovenian: Študija je pokazala, da so učinki dapagliflozina skladni z učinki drugih zdravil za zdravljenje sladkorne bolezni, ki prav tako delujejo z zaviranjem SGLT2.
English: For the full list of side effects and restrictions with Forxiga, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Forxiga glejte navodilo za uporabo.
English: Diabetes can occur when the body does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body cannot use insulin effectively.
Slovenian: Sladkorna bolezen se pojavi, kadar telo ne proizvaja dovolj insulina za vzdrževanje primerne ravni glukoze (sladkorja) v krvi ali kadar ga telo ne more učinkovito izrabiti.
English: Forxiga's common side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable.
Slovenian: Pogosti neželeni učinki zdravila Forxiga so povezani z načinom delovanja zdravila, npr. povečano število okužb spolovil in nekoliko redkeje okužb sečil, vendar jih je mogoče obvladati.
English: In type 1 diabetes, Forxiga is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Slovenian: Pri sladkorni bolezni tipa 1 se zdravilo Forxiga uporablja skupaj z insulinom pri bolnikih s prekomerno telesno maso (z indeksom telesne mase vsaj 27 kg/m2), če insulin sam ne zadostuje za ustrezno uravnavanje ravni sladkorja v krvi.
English: For type 1 diabetes, treatment with Forxiga should be started and supervised by a specialist in type 1 diabetes.
Slovenian: Pri sladkorni bolezni tipa 1 mora zdravljenje z zdravilom Forxiga uvesti in nadzorovati zdravnik specialist za sladkorno bolezen tipa 1.
English: If it is used with insulin or medicines that help the body produce insulin, the doses of these medicines may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Slovenian: Če se uporablja v kombinaciji z insulinom ali zdravili, ki spodbujajo tvorbo insulina, bo za zmanjšanje tveganja hipoglikemije (nizke ravni sladkorja v krvi) morda treba njihov odmerek zmanjšati.