FrancophonIA/ELRC3.0 huggingface dataset:
English: Humalog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Slovenian: Odmerke zdravila Humalog bo morda treba prilagoditi, če se jemlje sočasno z nekaterimi drugimi zdravili, ki bi lahko vplivala na raven glukoze v krvi.
English: The Committee recommended that Humalog be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Humalog izda dovoljenje za promet.
English: For the full list of all side effects and restrictions with Humalog, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Humalog glejte navodilo za uporabo.
English: Humalog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Slovenian: Zdravilo Humalog so proučevali v okviru osmih kliničnih študij s 2 951 bolniki s sladkorno boleznijo tipa 1 (pri kateri telo ne more tvoriti insulina) in sladkorne bolezni tipa 2 (pri kateri telo insulina ne more učinkovito izrabljati).
English: Humalog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Slovenian: Zdravilo Humalog lahko povzroči hipoglikemijo (nizko raven glukoze v krvi) in se ne sme dajati bolnikom, katerih raven glukoze v krvi je že tako nizka.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Humalog, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije glukoze v krvi ali pri kateri telo insulina ne more učinkovito uporabljati.
English: Humalog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Slovenian: Zdravilo Humalog 100 enot/ml se lahko daje tudi s kontinuirano infuzijo z insulinsko črpalko ali v veno.
English: Humalog is a replacement insulin which is very similar to the insulin made by the body.
Slovenian: Zdravilo Humalog je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja telo.
English: Humalog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Slovenian: Zdravili Humalog in Humulin R sta podobno učinkovali na nadzor sladkorne bolezni, kar so pokazale ravni HbA1c in ravni glukoze na tešče.
English: The active substance in Humalog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Slovenian: Zdravilno učinkovino v zdravilu Humalog, insulin lispro, proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v bakterijo vstavi gen (DNK), s katerim lahko tvori insulin lispro.
English: Humalog is used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.
Slovenian: Zdravilo Humalog se uporablja za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za nadzor glukoze (sladkorja) v krvi, vključno z bolniki, katerim je bila sladkorna bolezen šele diagnosticirana.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Humalog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Slovenian: Odbor za zdravila za humano uporabo (CHMP) je zaključil, da so koristi zdravila Humalog pri zdravljenju bolnikov s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje normalne homeostaze glukoze, pa tudi za začetno stabilizacijo sladkorne bolezni, večje od z njim povezanih tveganj.
English: Humalog Mix, Humalog Basal and Humalog 200 units/ml should never be given into a vein.
Slovenian: Zdravila Humalog Mix, Humalog Basal in Humalog 200 enot/ml se ne smejo dajati v veno.
English: Why has Humalog been approved?
Slovenian: Zakaj je bilo zdravilo Humalog odobreno?
English: The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog Basal), and combinations of both in various proportions (Humalog Mix):
Slovenian: Izdelki Humalog vsebujejo raztopine insulinov s hitrim delovanjem (Humalog), suspenzije insulinov z dolgotrajnejšim delovanjem (Humalog Basal) ter kombinacije obeh v različnih razmerjih (Humalog Mix):
English: Insulin lispro is available as Humalog in the soluble form, which acts more or less immediately after injection, and as Humalog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Slovenian: Insulin lispro je v zdravilu Humalog na voljo v topni obliki, zaradi česar večinoma učinkuje takoj po injekciji, ter v zdravilu Humalog Basal v obliki suspenzije protamina, ki se absorbira veliko počasneje in zato učinkuje dlje.
English: The effectiveness of Humalog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Slovenian: Učinkovitost zdravila Humalog so primerjali z učinkovitostjo zdravila Humulin R (topnega humanega insulina, nastalega s pomočjo tehnologije rekombinantne DNK), pri čemer so obe zdravili dodajali insulinom z dolgotrajnim delovanjem, ki se dajejo enkrat do dvakrat dnevno.
English: Humalog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Slovenian: Zdravilo Humalog se lahko uporablja z insulinom z daljšim delovanjem ali s sulfonilsečninami (skupino peroralnih zdravil za zdravljenje sladkorne bolezni).
English: Humalog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.
Slovenian: Zdravilo Humalog 200 enot/ml je treba injicirati pod kožo s peresnikom KwikPen, ki vsebuje zdravilo, pripravljeno za uporabo.
English: Humalog is a range of solutions and suspensions for injection that contain the active substance insulin lispro and are supplied in vials, cartridges and prefilled pens (Humalog KwikPen).
Slovenian: Zdravilo Humalog je vrsta raztopin in suspenzij za injiciranje, ki vsebujejo zdravilno učinkovino insulin lispro in so na voljo v vialah, injekcijskih vložkih in napolnjenih injekcijskih peresnikih (Humalog KwikPen).
English: Humalog, Humalog Basal and Humalog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Slovenian: Zdravila Humalog, Humalog Basal in Humalog Mix se dajejo subkutano (pod kožo) z injekcijo v nadlaket, stegno, zadnjico ali trebuh.
English: What is Humalog used for?
Slovenian: Za kaj se zdravilo Humalog uporablja?
English: How has Humalog been studied?
Slovenian: Kako je bilo zdravilo Humalog raziskano?
English: What is Humalog?
Slovenian: Kaj je zdravilo Humalog?
English: How is Humalog used?
Slovenian: Kako se zdravilo Humalog uporablja?
English: How does Humalog work?
Slovenian: Kako zdravilo Humalog deluje?
English: It is used in children and adolescents from 4 to 18 years of age.
Slovenian: Uporablja se pri otrocih in mladostnikih od 4. do 18. leta starosti).
English: What measures are being taken to ensure the safe and effective use of Verkazia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Verkazia?
English: Other information about Verkazia
Slovenian: Druge informacije o zdravilu Verkazia
English: Verkazia ciclosporin
Slovenian: Verkazia ciklosporin
English: It is not intended to provide practical advice on how to use Verkazia.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This is a summary of the European public assessment report (EPAR) for Verkazia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Verkazia.
English: What is Verkazia and what is it used for?
Slovenian: Kaj je zdravilo Verkazia in za kaj se uporablja?
English: In a main study involving 169 children and adolescents with severe VKC, 55% of patients treated with Verkazia achieved CFS improvements of 50% or more, without the need of other medications, after 4 months, compared with around 28% of patients receiving a dummy treatment.
Slovenian: V glavni študiji, ki je vključevala 169 otrok in mladostnikov s hudim VKC, je bilo pri 55 % bolnikov, zdravljenih z zdravilom Verkazia, po 4 mesecih doseženo izboljšanje CFS, ki je znašalo 50 % ali več, pri čemer ni bilo potrebe po drugih zdravilih, pri bolnikih, ki so prejemali placebo, pa jih je izboljšanje doseglo približno 28 %.
English: What benefits of Verkazia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Verkazia izkazalo v študijah?
English: The European Medicines Agency therefore decided that Verkazia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Verkazia večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Verkazia must not be used in patients with active or suspected infections in or around the eye.
Slovenian: Zdravilo Verkazia se ne sme uporabljati pri bolnikih z aktivnimi ali domnevnimi vnetji v očesu ali okoli njega.
English: The recommended dose is 1 drop 4 times a day in each affected eye, during VKC season.
Slovenian: Priporočeni odmerek je ena kapljica štirikrat dnevno v sezoni VKC v vsako prizadeto oko.
English: If symptoms persist after the end of the season, Verkazia can continue to be used at the recommended dose until symptoms are under control and at a reduced dose (1 drop twice a day) thereafter.
Slovenian: Če simptomi po sezoni ne izginejo, se lahko zdravilo Verkazia še naprej uporablja v priporočenem odmerku, dokler simptomi niso obvladani, in sicer v zmanjšanem odmerku (ena kapljica dvakrat dnevno).
English: Verkazia has been shown to be effective at improving the condition of the cornea and reducing the symptoms of the disease.
Slovenian: Zdravilo Verkazia se je izkazalo za učinkovito pri izboljšanju stanja roženice in zmanjševanju simptomov bolezni.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Verkazia 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 Verkazia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What are the risks associated with Verkazia?
Slovenian: Kakšna tveganja so povezana z zdravilom Verkazia?
English: The most common side effects with Verkazia are eye pain and itching, which may affect around 1 in 10 people.
Slovenian: Najpogostejši neželeni učinki zdravila Verkazia so bolečine v očeh in srbenje oči, ki lahko prizadenejo približno 1 osebo od 10.
English: Side effects are mostly mild and disappear shortly after application of the medicine.
Slovenian: Neželeni učinki so večinoma blagi in kmalu po dajanju zdravila izginejo.
English: Because the number of patients with vernal keratoconjunctivitis is low, the disease is considered ‘rare', and Verkazia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 April 2006.
Slovenian: Ker je bolnikov s vernalnim keratokonjunktivitisom malo, velja ta bolezen za redko, zato je bilo zdravilo Verkazia 6. aprila 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Applying it directly to the eye reduces eye inflammation but limits its effects elsewhere in the body.
Slovenian: Nanos zdravila neposredno v oko zmanjša vnetje očesa, omeji pa učinke zdravila drugje v telesu.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verkazia have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Verkazia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The active substance in Verkazia, ciclosporin, blocks cells of the immune system (the body's natural defences) that are involved in the processes that cause the allergic reaction and inflammation in patients with VKC.
Slovenian: Učinkovina v zdravilu Verkazia, ciklosporin, zavira celice imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki pri bolnikih z VKC povzročajo alergijsko reakcijo in vnetje.
English: Verkazia is a medicine used to treat severe vernal keratoconjunctivitis (VKC), an allergic condition that affects the eye and mostly occurs seasonally, although in some patients symptoms can recur or persist all year round.
Slovenian: Zdravilo Verkazia se uporablja za zdravljenje hudega vernalnega keratokonjunktivitisa (VKC), alergijskega stanja, ki prizadene oči in se najpogosteje pojavlja sezonsko, čeprav se simptomi lahko pri nekaterih bolnikih ponovno pojavijo ali vztrajajo v katerem koli letnem času.
English: For more information about treatment with Verkazia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Verkazia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Verkazia approved?
Slovenian: Zakaj je bilo zdravilo Verkazia odobreno?
English: Verkazia is available as eye drops.
Slovenian: Zdravilo Verkazia je na voljo v obliki kapljic za oči.
English: These symptoms usually occur when the drops are being put in the eyes and go away shortly after.
Slovenian: Do teh simptomov običajno pride ob dajanju kapljic v oko in hitro po tem izginejo.
English: The full EPAR for Verkazia 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 Verkazia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For the full list of all side effects and restrictions with Verkazia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Verkazia glejte navodilo za uporabo.
English: Verkazia contains the active substance ciclosporin.
Slovenian: Zdravilo Verkazia vsebuje učinkovino ciklosporin.
English: For practical information about using Verkazia, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Verkazia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Verkazia can only be obtained with a prescription and treatment must be started by a healthcare professional qualified in ophthalmology (eye medicine).
Slovenian: Predpisovanje in izdaja zdravila Verkazia je le na recept, zdravljenje z njim pa sme uvesti samo zdravstveni delavec, usposobljen na področju oftalmologije (očesne medicine).
English: Some of the patients were treated for an additional 8 months; this extension study showed that the benefits of Verkazia were maintained with continued use for up to 12 months.
Slovenian: V tej podaljšani študiji je bilo dokazano, da so se koristi zdravila Verkazia ohranile tudi pri neprekinjeni uporabi v obdobju do 12 mesecev.
English: How is Verkazia used?
Slovenian: Kako se zdravilo Verkazia uporablja?
English: How does Verkazia work?
Slovenian: Kako zdravilo Verkazia deluje?
English: Verkazia reduces damage to the cornea (layer in the front of the eye) in most patients with VKC as shown by improvements in ‘corneal fluorescence staining' (CFS) scores (a standard measure of corneal health).
Slovenian: Kot dokazujejo izboljšave rezultatov pri obarvanju roženice s fluorescentnim barvilom („corneal fluorescence staining“ (CFS)) (kar je standardno merilo zdravja roženice), zdravilo Verkazia pri večini bolnikov z VKC zmanjšuje poškodbe roženice (plasti na sprednjem delu očesa).
English: Symptoms such as itching, fluid or mucous discharge and light sensitivity also improved in patients treated with Verkazia to a greater extent than with the dummy treatment.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Verkazia, so se v primerjavi z bolniki, ki so prejemali placebo, bolj izboljšali simptomi, kot so srbenje, izcedek v obliki tekočine ali sluzi in občutljivost na svetlobo.
English: Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily.
Slovenian: Začetni odmerki znašajo od 0,1 do 0,3 mg na kilogram telesne mase na dan. Nato se
English: Tacforius should be taken once daily with water, on an empty stomach.
Slovenian: Zdravilo Tacforius je treba jemati enkrat dnevno skupaj z vodo na prazen želodec.
English: What measures are being taken to ensure the safe and effective use of Tacforius?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tacforius?
English: The prolonged-release capsules allow tacrolimus to be released slowly from the capsule over several hours so that it needs to be taken only once a day.
Slovenian: Kapsule s podaljšanim sproščanjem omogočajo, da se takrolimus več ur počasi sprošča iz kapsule, tako da jih je treba jemati le enkrat dnevno.
English: The full EPAR for Tacforius 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 Tacforius je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tacforius.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tacforius.
English: As for every medicine, the company provided studies on the quality of Tacforius.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Tacforius.
English: The Agency recommended that Tacforius be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo Tacforius odobri za uporabo v EU.
English: Because Tacforius 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 Tacforius generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Tacforius?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Tacforius?
English: It is not intended to provide practical advice on how to use Tacforius.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Advagraf, and do not need to be repeated for Tacforius.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Advagraf, zato jih ni treba ponoviti za zdravilo Tacforius.
English: Other information about Tacforius
Slovenian: Druge informacije o zdravilu Tacforius
English: The European Medicines Agency concluded that, in accordance with EU requirements, Tacforius has been shown to have comparable quality and to be bioequivalent to Advagraf.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Tacforius primerljivo raven kakovosti kot referenčno zdravilo Advagraf ter da mu je biološko enakovredno.
English: This means that Tacforius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Advagraf.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Advagraf, ki je že odobreno v Evropski uniji (EU).
English: For more information about treatment with Tacforius, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tacforius preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The doses are then adjusted according to the patient's response and the medicine's blood levels.
Slovenian: odmerki prilagodijo glede na bolnikov odziv in koncentracije zdravila v krvi.
English: What is Tacforius and what is it used for?
Slovenian: Kaj je zdravilo Tacforius in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tacforius have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tacforius upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Tacforius can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Slovenian: Zdravilo se lahko uporablja tudi za zdravljenje zavrnitve organa pri odraslih bolnikih, če druga imunosupresivna zdravila (zdravila, ki zavirajo delovanje imunskega sistema) niso učinkovita.
English: Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe it and make changes to immunosuppressive treatment.
Slovenian: Samo zdravniki, ki imajo izkušnje z imunosupresivnimi zdravili in vodenjem bolnikov po transplantaciji), lahko predpisujejo zdravilo in spreminjajo imunosupresivno zdravljenje.
English: Tacforius tacrolimus
Slovenian: Tacforius takrolimus
English: Doses of Tacforius are calculated on the basis of the patient's weight and the type of transplant the patient has had.
Slovenian: Odmerki zdravila Tacforius se izračunajo na podlagi bolnikove telesne mase in vrste bolnikovega presadka.
English: For practical information about using Tacforius, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Tacforius naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Tacforius is available as prolonged-release capsules containing tacrolimus.
Slovenian: Zdravilo Tacforius je na voljo v obliki kapsul s podaljšanim sproščanjem, ki vsebujejo takrolimus.
English: Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).
Slovenian: Takrolimus zavira delovanje celic imunskega sistema, imenovanih celice T, ki so zlasti vključene pri napadu na presajeni organ (pri zavrnitvi organa).
English: Tacforius contains the active substance tacrolimus and is a ‘generic medicine'.
Slovenian: Zdravilo Tacforius vsebuje zdravilno učinkovino takrolimus in je „generično zdravilo“.