FrancophonIA/ELRC3.0 huggingface dataset:
English: Adding Orencia and methotrexate to existing treatment for 12 months reduced symptoms in 61% of the patients (70 out of 115), compared with 42% of the patients on Orencia alone (48 out of 113) and 45% of the patients on methotrexate alone (52 out of 115).
Slovenian: Dodajanje zdravila Orencia in metotreksata obstoječemu zdravljenju je v 12 mesecih privedlo do zmanjšanja simptomov pri 61 % (70 od 115) bolnikov v primerjavi z 42 % (48 od 113) bolnikov, ki so zdravilo Orencia jemali kot samostojno zdravilo, in 45 % (52 od 115) tistih, ki so jemali samo metotreksat.
English: The second study found a similar effect of Orencia on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
Slovenian: V drugi študiji je bil po enem letu zdravljenja ugotovljen podoben učinek zdravila Orencia na simptome revmatoidnega artritisa, poleg tega pa sta bili ugotovljeni boljša funkcijska zmogljivost in manj poškodb sklepov.
English: Adding Orencia to existing treatment led to a reduction in symptoms in 50% of the patients (129 out of 256) after 6 months, compared with 20% of the patients adding placebo (26 out of 133).
Slovenian: Dodajanje zdravila Orencia obstoječemu zdravljenju je v šestih mesecih privedlo do zmanjšanja simptomov pri 50 % (129 od 256) bolnikov v primerjavi z 20 % (26 od 133) bolnikov, pri katerih so dodajali placebo.
English: Over 6 months, 20% of the patients receiving Orencia had a flare-up (12 out of 60), compared with 53% of those receiving placebo (33 out of 62).
Slovenian: V šestih mesecih je bolezen ponovno izbruhnila pri 20 % (12 od 60) bolnikov, ki so prejemali zdravilo Orencia, in pri 53 % (33 od 62) tistih, ki so prejemali placebo.
English: T cells are immune system cells that are involved in causing the inflammation in rheumatoid, psoriatic and polyarticular juvenile idiopathic arthritis.
Slovenian: Učinkovina v zdravilu Orencia, abatacept, je beljakovina, ki zavira aktivacijo celic T. Celice T so imunske celice, ki sodelujejo pri povzročanju vnetja pri revmatoidnem, psoriatičnem in poliartikularnem juvenilnem idiopatskem artritisu.
English: Orencia was found effective in one main study involving 424 adult patients with psoriatic arthritis.
Slovenian: V eni glavni študiji, ki je vključevala 424 odraslih bolnikov s psoriatičnim artritisom, so ugotovili, da je zdravilo Orencia učinkovito.
English: It is used alone or in combination with methotrexate for patients who do not need other medicines by mouth or by injection to control their psoriasis.
Slovenian: Pri bolnikih, ki za obvladovanje psoriaze ne potrebujejo drugih zdravil, ki se dajejo peroralno ali z injiciranjem, se uporablja kot samostojno zdravilo ali v kombinaciji z metotreksatom.
English: See also Serious allergic reaction above.
Slovenian: Glejte tudi podpoglavje Resna alergijska reakcija zgoraj.
English: 41% 32% Odds Ratio:
Slovenian: 41 % 32 % Razmerje obetov:
English: If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Slovenian: Če je prilagoditev potrebna, utegne biti potrebna že pri prvem odmerku ali v prvih nekaj tednih ali mesecih.
English: The injection can be given at any time during the day, but at the same time each day.
Slovenian: Odmerek se lahko injicira kadar koli v dnevu, vendar vsak dan ob istem času.
English: Baseline values for these parameters were similar in the two groups.
Slovenian: Izhodiščne vrednosti teh parametrov so bile med skupinama podobne.
English: Select the dose you need.
Slovenian: Izberite si odmerek, ki ga potrebujete.
English: Difference:
Slovenian: Razlika:
English: Ask your doctor about this.
Slovenian: O tem povprašajte svojega zdravnika.
English: How often to inject
Slovenian: Kako pogosto injicirati
English: Date of last renewal: 16 April 2009
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 16. april 2009
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 June 2004
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 01. junij 2004
English: The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%.
Slovenian: Celotni odstotek zdravljenih bolnikov, pri katerih lahko pričakujemo neželene učinke, se ocenjuje na 12 %.
English: Careful monitoring is recommended in these patients.
Slovenian: Pri teh bolnikih je priporočljivo skrbno nadziranje.
English: Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Slovenian: Glukozo je treba dati intravensko v primeru, da se bolnik v 10 do 15 minutah ne odzove na glukagon.
English: Intramuscular administration should also be avoided.
Slovenian: Intramuskularnemu apliciranju se je treba izogibati.
English: Most of the injection site reactions are minor and of a transitory nature, i.e. they normally disappear during continued treatment in a few days to a few weeks.
Slovenian: Večina reakcij na mestu injiciranja je blagih in prehodnih, tj. med nadaljevanjem zdravljenja običajno izginejo v nekaj dneh do nekaj tednih.
English: Your dose may have to be adjusted by your doctor if:
Slovenian: Zdravnik bo odmerek morda moral prilagoditi, če:
English: No change in dose (target)
Slovenian: brez spremembe odmerka (ciljna vrednost je dosežena)
English: Levemir which has been frozen must not be used.
Slovenian: Zdravila Levemir, ki je bil zamrznjen, ne smete uporabiti.
English: Maximum serum concentration is reached between 6 and 8 hours after administration.
Slovenian: Največja koncentracija v serumu je dosežena v 6 do 8 urah po aplikaciji.
English: The trial including children above 2 years was extended for an additional 12 months (total of 24 months treatment data) to assess antibody formation after long-term treatment with Levemir.
Slovenian: Preskušanje, ki je vključevalo otroke, starejše od 2 let, so podaljšali za dodatnih 12 mesecev (skupaj 24 mesecev podatkov o zdravljenju) za oceno nastajanja protiteles po dolgotrajnem zdravljenju z zdravilom Levemir.
English: However, when used in combination with oral antidiabetic medicinal products, three clinical studies have shown a frequency of common (2.2% of allergic reactions and potentially allergic reactions have been observed).
Slovenian: Toda med uporabo v kombinaciji s peroralnimi antidiabetiki so v treh kliničnih študijah ugotovili, da je to pogost neželeni učinek (opažali so 2,2 % alergijskih reakcij in potencialnih alergijskih reakcij).
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
English: The duration of action is up to 24 hours depending on dose providing an opportunity for once or twice daily administration.
Slovenian: Trajanje delovanja je odvisno od odmerka in lahko znaša do 24 ur, kar omogoča enkrat ali dvakrat dnevno apliciranje.
English: Levemir must be protected from excessive heat and light.
Slovenian: Zdravilo Levemir je treba zaščititi pred čezmerno toploto in svetlobo.
English: Treatment with Levemir can be considered during pregnancy, but any potential benefit must be weighed against a possibly increased risk of an adverse pregnancy outcome.
Slovenian: Zdravilo Levemir se lahko uporabi med nosečnostjo, vendar je treba morebitno korist pretehtati v primerjavi z možnim povečanjem tveganja za neželeni izid nosečnosti.
English: Overall number of major hypoglycaemia episodes during pregnancy (per patient year)
Slovenian: Celotno število hujših hipoglikemij med nosečnostjo (na bolnica-leto)
English: *Self-Monitored Plasma Glucose
Slovenian: * samoizmerjena glukoza v plazmi
English: An apparent volume of distribution for Levemir (approximately 0.1 l/kg) indicates that a high fraction of insulin detemir is circulating in the blood.
Slovenian: Navidezen volumen porazdelitve zdravila Levemir (približno 0,1 l/kg) kaže na to, da se velik delež insulina detemir nahaja v krvnem obtoku.
English: From clinical investigations, it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir.
Slovenian: Iz kliničnih raziskav je znano, da se hude hipoglikemije - opredeljene kot takšne, pri katerih je nujno posredovanje nekoga drugega - pojavijo pri približno 6 % bolnikov, zdravljenih z zdravilom Levemir.
English: Proportions of patients achieving HbA1c <7% targets
Slovenian: Deleži bolnikov, ki so dosegli ciljno vrednost HbA1c < 7 %
English: Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimester.
Slovenian: Potreba po insulinu se v prvem trimesečju ponavadi zmanjša, potem pa se v drugem in tretjem trimesečju zveča.
English: However, this does not appear to have any impact on glycaemic control.
Slovenian: Vendar ne kaže, da bi to vplivalo na urejenost glikemije.
English: Observed rates of minor hypoglycaemic episodes were similar and no severe hypoglycaemic episodes were observed in either group.
Slovenian: Opaženi delež blagih hipoglikemičnih epizod je bil med skupinama podoben, v nobeni skupini pa niso opazili hudih hipoglikemičnih epizod.
English: It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Slovenian: Uporabljati ga je mogoče tudi v kombinaciji s peroralnimi antidiabetiki in/ali agonisti receptorjev GLP-1.
English: Time Since Insulin Injection (hours) Levemir ….. 0.2 U/kg 0.3 U/kg .
Slovenian: Čas od injiciranja insulina (v urah) Levemir ….. 0,2 e./kg 0,3 e./kg .
English: Primary objective of this study was to assess the effect of Levemir on blood glucose regulation in pregnant women with diabetes (see section 5.1).
Slovenian: Primarni cilj študije je bil oceniti učinek zdravila Levemir na uravnavanje glukoze v krvi pri nosečnicah s sladkorno boleznijo (glejte poglavje 5.1).
English: The most frequently reported adverse reaction during treatment is hypoglycaemia, please see section 4.8, Description of selected adverse reactions.
Slovenian: Najpogosteje opisani neželeni učinek med zdravljenjem je hipoglikemija; glejte poglavje 4.8, podpoglavje Opis izbranih neželenih učinkov.
English: Levemir can be used in elderly patients.
Slovenian: Zdravilo Levemir lahko uporabite pri starejših bolnikih.
English: Adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Slovenian: Spodaj navedeni neželeni učinki temeljijo na podatkih iz kliničnih preskušanj in so razvrščeni po MedDRA pogostnosti in organskih sistemih.
English: Duration of action (hr) GIRmax (mg/kg/min) †estimated values
Slovenian: Trajanje delovanja (h) GIRmax (mg/kg/min) †ocenjene vrednosti
English: NPH insulin CV (%)
Slovenian: Insulin NPH CV (%)
English: This should be kept in mind if treatment with the combination of pioglitazone and Levemir is considered.
Slovenian: To je treba upoštevati pri načrtovanju zdravljenja s kombinacijo pioglitazona in zdravila Levemir.
English: Discuss this with your doctor.
Slovenian: O tem se posvetujte z zdravnikom.
English: *Insulin detemir is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Slovenian: * Insulin detemir je pridobljen iz Saccharomyces cerevisiae s tehnologijo rekombinantne DNA.
English: Animal data do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Your InnoLet is designed to work accurately and safely.
Slovenian: Vaš injekcijski peresnik InnoLet je izdelano za natančno in varno delovanje.
English: You must never inject Levemir directly into a vein (intravenously) or muscle (intramuscularly).
Slovenian: Zdravila Levemir si nikoli ne smete injicirati neposredno v veno (intravensko) ali mišico (intramuskularno).
English: Receptor affinity data and in vitro mitogenicity tests revealed no evidence of an increased mitogenic potential compared to human insulin.
Slovenian: Podatki o receptorski afiniteti in in-vitro poskusi mitogenosti niso pokazali povečanega mitogenega potenciala v primerjavi s humanim insulinom.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Slovenian: Prilagoditev odmerka je lahko potrebna tudi v primeru večje telesne aktivnosti, spremenjene običajne prehrane ali med spremljajočimi boleznimi.
English: Glucose infusion rate (mg/kg/min)
Slovenian: Hitrost infuzije glukoze (mg/kg/min)
English: The terminal half-life after subcutaneous administration is determined by the rate of absorption from the subcutaneous tissue.
Slovenian: Terminalni razpolovni čas po subkutani aplikaciji je določen s hitrostjo absorpcije iz podkožnega tkiva.
English: B. Check that the insulin in your pen is clear and colourless.
Slovenian: B. Preverite, da je insulin v injekcijskem peresniku bister in brezbarven.
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov (glejte poglavje 6.1).
English: During use: Use within 6 weeks
Slovenian: Med uporabo: porabite v 6 tednih.
English: Change in body weight after insulin treatment Study duration Levemir once daily
Slovenian: Sprememba telesne mase po zdravljenju z insulinom Trajanje študije Zdravilo Levemir enkrat na dan
English: Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Skupine pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki
English: It is unknown whether insulin detemir is excreted in human milk.
Slovenian: Ni znano, ali se insulin detemir izloča v materino mleko.
English: During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
Slovenian: Med uporabo in ko se zdravilo uporablja kot rezerva: zdravilo je lahko shranjeno največ 6 tednov.
English: The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units.
Slovenian: Moč insulinskih analogov, tudi insulina detemir, izražamo v enotah, moč humanega insulina pa v mednarodnih enotah.
English: The pharmacokinetic properties of Levemir were investigated in young children (1-5 years), children (6-12 years) and adolescents (13-17 years) and compared to adults with type 1 diabetes.
Slovenian: Farmakokinetične lastnosti zdravila Levemir so raziskali pri mlajših otrocih (od 1. do 5. leta), otrocih (od 6. do 12. leta) in mladostnikih (od 13. do 17. leta) in jih primerjali s tistimi pri odraslih s sladkorno boleznijo tipa 1.
English: If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
Slovenian: Če imate zmanjšano funkcijo ledvic ali jeter, ali če ste starejši od 65 let, morate krvni sladkor kontrolirati bolj redno, o spremembah odmerka insulina pa se morate posvetovati z zdravnikom.
English: The 39% of patients not achieving target were randomised to have Levemir once-daily added or continue on liraglutide+metformin for 52 weeks.
Slovenian: 39 % bolnikov, ki niso dosegli cilja, pa so randomizirali bodisi na dodatek zdravila Levemir enkrat na dan bodisi na nadaljevanje kombinacij liraglutid + metformin za 52 tednov.
English: Levemir was the basal insulin product for 33% (n=147) of the patients (97.3% using metformin).
Slovenian: Zdravilo Levemir je bil bazalni insulin pri 33 % (N = 147) vseh bolnikov (97,3 % bolnikov je uporabljalo tudi metformin).
English: Levemir CV (%)
Slovenian: CV (%)
English: Pharmacodynamic Parameters for Levemir and NPH
Slovenian: Farmakodinamični parametri za Levemir in NPH
English: • Screw the needle straight and tightly onto your InnoLet (picture A).
Slovenian: • Iglo naravnost in trdno privijte na vaš injekcijski peresnik InnoLet (slika A).
English: • Always check that the push-button is fully depressed and the dose selector is set to 0.
Slovenian: • Vedno preverite, da je potisni gumb povsem dol in da je izbirnik odmerka nastavljen na 0.
English: The terminal half-life is between 5 and 7 hours depending on the dose.
Slovenian: Terminalni razpolovni čas je odvisen od odmerka in znaša od 5 do 7 ur.
English: • Drink alcohol (see section 2 Drinking alcohol and taking Levemir).
Slovenian: • če pijete alkohol (glejte poglavje 2, podpoglavje Zdravilo Levemir skupaj z alkoholom).
English: Levemir can be used in adolescents and children from the age of 1 year (see section 5.1).
Slovenian: Zdravilo Levemir se lahko uporablja pri mladostnikih in otrocih, starejših od 1 leta (glejte poglavje 5.1).
English: ► If you are treated with Levemir Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.
Slovenian: ► Če se zdravite z zdravilom Levemir Penfill in še drugim insulinom v vložkih Penfill, morate uporabljati dva sistema za dajanje insulina, enega za vsako vrsto insulina.
English: Changing the site with each injection reduces the risk of developing such skin changes.
Slovenian: Menjavanje injekcijskega mesta pri vsaki injekciji zmanjša tveganje za nastanek takšnih kožnih sprememb.
English: Levemir twice daily
Slovenian: Zdravilo Levemir dvakrat na dan
English: For doses in the interval of 0.2-0.4 units/kg (U/kg), Levemir exerts more than 50% of its maximum effect from 3-4 hours and up to approximately 14 hours after dose administration.
Slovenian: V odmerkih zdravila Levemir v območju od 0,2-0,4 enot/kg (e./kg) znaša trajanje učinka, večjega od 50 % največjega učinka, od 3-4 ur do približno 14 ur po apliciranju odmerka.
English: Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Slovenian: Diabetična retinopatija (s sladkorno boleznijo povezana bolezen oči, ki lahko povzroči izgubo vida): če imate diabetično retinopatijo in se vam koncentracija krvnega sladkorja zelo hitro izboljša, se vam lahko retinopatija poslabša.
English: Concomitant antidiabetic treatment may need to be adjusted (dose and/or timing of oral antidiabetic medicinal products or concurrent short/rapid-acting insulin medicinal products).
Slovenian: Spremljajoče zdravljenje sladkorne bolezni je morda treba prilagoditi (odmerek in/ali čas uporabe peroralnih antidiabetikov ali dajanja sočasno uporabljenih kratko-/hitrodelujočih insulinskih zdravil).
English: Serious allergic reaction to Levemir or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening.
Slovenian: Resna alergijska reakcija na zdravilo Levemir ali katero od njegovih sestavin (to imenujemo sistemska alergijska reakcija) je zelo redek, a potencialno smrtno nevaren neželeni učinek.
English: Results indicate that antibody development had no negative effect on glycaemic control and Levemir dose.
Slovenian: Rezultati kažejo, da pojav protiteles nima negativnega vpliva na urejenost glikemije in odmerek zdravila Levemir.
English: What you need to know before you use Levemir
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Levemir
English: To see precisely how much insulin is left use the dose counter: Turn the dose selector until the dose counter stops.
Slovenian: Če želite videti, koliko insulina je še ostalo, uporabite števec odmerka: Vrtite izbirnik odmerka dokler se števec odmerka ne ustavi.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Slovenian: • Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z glukagonom (0,5 do 1 mg), ki ga da intramuskularno ali subkutano ustrezno podučena oseba, ali z glukozo, ki jo da intravensko zdravstveni delavec.
English: Efficacy and safety data for adolescent patients with type 2 diabetes mellitus have been extrapolated from data for children, adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.
Slovenian: Podatki o učinkovitosti in varnosti za mladostnike s sladkorno boleznijo tipa 2 so ekstrapolirani iz podatkov, pridobljenih pri otrocih, mladostnikih in odraslih s sladkorno boleznijo tipa 1 ter odraslih s sladkorno boleznijo tipa 2.
English: The trial started with a 12-week run-in period with liraglutide+metformin, where 61% reached an HbA1c <7%.
Slovenian: Začelo se je z 12-tedenskim obdobjem uvajanja s kombinacijo liraglutid + metformin; med tem obdobjem je 61 % preiskovancev doseglo HbA1c < 7 %.
English: When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.
Slovenian: Ko je peresnik prazen, ga pazljivo zavrzite brez nameščene igle, kot vam je to naročil vaš zdravnik, medicinska sestra ali farmacevt, v skladu z lokalnimi predpisi.
English: Randomised liraglutide + metformin n=149
Slovenian: metformin n = 149
English: 1 unit insulin detemir corresponds to 1 international unit of human insulin.
Slovenian: Ena enota insulina detemir ustreza 1 mednarodni enoti humanega insulina.
English: • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Slovenian: • simpatikomimetike (na primer adrenalin, salbutamol, terbutalin, uporabljajo se za zdravljenje astme),
English: In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Slovenian: Na splošno sta pri ženskah s sladkorno boleznijo med celotno nosečnostjo in pred nameravano nosečnostjo priporočljiva intenzivnejša kontrola glukoze v krvi in spremljanje nosečnice.
English: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the dose and timing of administration may be necessary (see section 4.4).
Slovenian: Pri prehodu z drugih srednjedolgodelujočih ali dolgodelujočih insulinskih zdravil je lahko potrebna prilagoditev odmerka in časa apliciranja (glejte poglavje 4.4).
English: What Levemir is and what it is used for
Slovenian: Kaj je zdravilo Levemir in za kaj ga uporabljamo
English: • After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered.
Slovenian: • Po injiciranju mora igla ostati pod kožo vsaj 6 sekund, da je zanesljivo vbrizgan celotni odmerek.