FrancophonIA/ELRC3.0 huggingface dataset:
English: The 30 ml stock solution is to be diluted immediately by adding the 30 ml stock solution to either 500 ml glucose 50 mg/ml (5%) solution for injection or 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection in glass containers.
Slovenian: mg/ml (5-odstotne) raztopine za injiciranje ali 500 ml 9-mg/ml (0,9-odstotne) raztopine natrijevega klorida za injiciranje v steklenih vsebnikih.
English: Hepatobiliary disorders
Slovenian: Biotransformacija
English: SOLVENT AMPOULE
Slovenian: OVOJNINAH AMPULA Z VEHIKLOM
English: The infusion should last around 1 to 2 hours.
Slovenian: Infundiranje traja od 1 do 2 ur.
English: However, further data are needed on the long-term benefits and safety of the medicine.
Slovenian: Kljub temu pa so potrebni dodatni podatki o dolgoročnih koristih in varnosti zdravila.
English: Regarding safety, no major issues have been identified and serious side effects were rare or manageable.
Slovenian: Glede varnosti ni odkril nobenih velikih težav, resni neželeni učinki pa so bili redki ali obvladljivi.
English: Kanuma sebelipase alfa
Slovenian: Kanuma sebelipaza alfa
English: What measures are being taken to ensure the safe and effective use of Kanuma?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kanuma?
English: Kanuma should be started as early as possible after diagnosis and is intended for long-term use.
Slovenian: Zdravilo Kanuma je treba uvesti čim prej po diagnozi in je namenjeno dolgotrajni uporabi.
English: Other information about Kanuma
Slovenian: Druge informacije o zdravilu Kanuma
English: If antibodies develop, Kanuma may not work effectively.
Slovenian: Če pride do razvoja protiteles, zdravilo Kanuma morda ne bo učinkovito.
English: What benefits of Kanuma have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kanuma izkazalo v študijah?
English: These include chest discomfort, red eyes, eyelid swelling, difficulty breathing, itchy rash, hives, flushing, runny nose, rapid heartbeat and rapid breathing.
Slovenian: Ti vključujejo neugodje v prsnem košu, rdeče oči, otekanje vek, težave pri dihanju, srbeč izpuščaj, koprivnico, zardevanje, izcedek iz nosu, hiter srčni utrip in hitro dihanje.
English: The first study involved 9 infants with growth failure or other evidence of rapidly progressing disease in their first 6 months of life.
Slovenian: Prva študija je vključila 9 dojenčkov s poslabšano rastjo ali drugim dokazom hitro napredujoče bolezni v prvih 6 mesecih življenja.
English: The most serious side effects with Kanuma (seen in around 3 patients in 100) are signs and symptoms of severe allergic reactions.
Slovenian: Najresnejši neželeni učinki zdravila Kanuma (ki so jih opazili pri približno 3 bolnikih od 100) so znaki in simptomi hudih alergijskih reakcij.
English: The study showed that 6 out of the 9 infants given Kanuma survived to 1 year of age.
Slovenian: V študiji so pokazali, da je 6 od 9 dojenčkov, ki so prejemali zdravilo Kanuma, preživelo do 1 leta starosti.
English: A risk management plan has been developed to ensure that Kanuma is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Kanuma je bil pripravljen načrt obvladovanja tveganj.
English: The main measure of effectiveness was the proportion of patients who achieved normal levels of a liver enzyme called ALT after 5 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so dosegli normalne ravni jetrnega encima, imenovanega ALT, po 5 mesecih zdravljenja.
English: This is a summary of the European public assessment report (EPAR) for Kanuma.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kanuma.
English: Treatment should be given by a trained healthcare professional who can manage medical emergencies (such as a severe allergy).
Slovenian: Zdravljenje mora izvajati usposobljen zdravstveni delavec, ki obvlada zdravljenje v nujnih primerih (kot je huda alergija).
English: What is Kanuma and what is it used for?
Slovenian: Kaj je zdravilo Kanuma in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Kanuma.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In this study, 31% of the patients given Kanuma (11 out of 36) achieved normal levels of ALT enzymes, compared with 7% of the patients given placebo (2 out of 30).
Slovenian: V tej študiji je 31 % bolnikov, zdravljenih z zdravilom Kanuma (11 od 36), doseglo normalne ravni encima ALT v primerjavi s 7 % bolnikov, ki so prejemali placebo (2 od 30).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kanuma 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 Kanuma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What are the risks associated with Kanuma?
Slovenian: Kakšna tveganja so povezana z zdravilom Kanuma?
English: Growth improvements were also observed in all 6 surviving infants.
Slovenian: Pri vseh 6 preživelih dojenčkih so prav tako opazili izboljšanje rasti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kanuma's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Kanuma večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Development of antibodies against the medicine has also been reported especially in infants.
Slovenian: Prav tako so poročali o razvoju protiteles proti temu zdravilu, predvsem pri dojenčkih.
English: Why is Kanuma approved?
Slovenian: Zakaj je bilo zdravilo Kanuma odobreno?
English: The CHMP considered that Kanuma led to significant improvements in survival in infants, and was effective at improving symptoms of the disease in patients of all ages.
Slovenian: Odbor CHMP je ugotovil, da je zdravilo Kanuma povzročilo pomembno izboljšanje preživetja dojenčkov in je bilo učinkovito pri izboljšanju simptomov bolezni pri bolnikih vseh starosti.
English: Because the number of patients with lysosomal acid lipase deficiency is low, the disease is considered ‘rare', and Kanuma was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December 2010.
Slovenian: Ker je bolnikov s pomanjkanjem lizosomnega encima kisle lipaze malo, velja ta bolezen za redko, zato je bilo zdravilo Kanuma 17. decembra 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: It must also not be used in patients with life-threatening allergy to eggs or any of Kanuma's ingredients.
Slovenian: Prav tako se ga ne sme uporabljati pri bolnikih s smrtno nevarno alergijo na jajca ali katero koli sestavino zdravila Kanuma.
English: In addition, the company that markets Kanuma is carrying out a study in infants with rapidly progressing disease and will set-up a registry of patients of all ages to obtain further information on the long-term benefits and safety of Kanuma, in particular on the risk of allergic reactions and the development of antibodies against the medicine.
Slovenian: Poleg tega družba, ki trži zdravilo Kanuma, izvaja študijo pri dojenčkih s hitro napredujočo boleznijo in bo vzpostavila register bolnikov vseh starosti, s katerim bo pridobila dodatne podatke o dolgoročnih koristih in varnosti zdravila Kanuma, predvsem glede tveganja alergijskih reakcij in razvoja protiteles proti zdravilu.
English: Sebelipase alfa replaces the missing enzyme, helping to break down fats and stopping them building up in the body's cells.
Slovenian: Sebelipaza alfa nadomesti manjkajoči encim, kar pomaga razgraditi maščobe in zaustavi njihovo kopičenje v celicah.
English: The second study involved 66 patients (children and adults) and compared Kanuma with placebo (a dummy treatment).
Slovenian: V drugi študiji, ki je vključila 66 bolnikov (otrok in odraslih), so zdravilo Kanuma primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The company will also provide educational material to all doctors expected to prescribe Kanuma, encouraging them to enroll patients in the registry and informing them of how to monitor patients for antibodies and manage patients who develop severe allergic reactions.
Slovenian: Družba bo prav tako pripravila izobraževalno gradivo za vse zdravnike, ki bodo predpisovali zdravilo Kanuma, s katerim jih bo spodbujala, naj bolnike vključijo v register, in jih obvestila o načinu spremljanja protiteles ter obravnavi bolnikov, pri katerih se razvijejo hude alergijske reakcije.
English: When the enzyme is absent or present only in low levels, fats accumulate in the body's cells, causing symptoms such as growth failure and liver damage.
Slovenian: Če je ta encim odsoten ali je njegova raven zelo nizka, se maščobe kopičijo v celicah, kar povzroča simptome, kot sta upočasnjena rast in poškodba jeter.
English: For more information about treatment with Kanuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kanuma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The full EPAR and risk management plan summary for Kanuma 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) in povzetek načrta obvladovanja tveganj za zdravilo Kanuma sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Kanuma must not be used in patients who have had a life-threatening allergic reaction to the active substance which re-occurred after stopping and starting treatment again.
Slovenian: Zdravilo Kanuma se ne sme uporabljati pri bolnikih, ki so imeli smrtno nevarno alergijsko reakcijo na zdravilno učinkovino, ki se je ponovila po prekinitvi in ponovni uvedbi zdravljenja.
English: The recommended dose is 1 mg per kilogram body weight given once every other week.
Slovenian: Priporočeni odmerek zdravila Kanuma je 1 mg na kilogram telesne mase, daje pa se enkrat na dva tedna.
English: The Committee noted the lack of any effective treatments for lysosomal acid lipase deficiency and the high mortality in infants with rapidly progressing disease.
Slovenian: Odbor je upošteval pomanjkanje učinkovitih oblik zdravljenja pomanjkanja lizosomnega encima kisle lipaze in veliko umrljivost pri dojenčkih s hitro napredujočo boleznijo.
English: Kanuma is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Kanuma je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (vbrizganje) v veno.
English: Treatment with Kanuma should be supervised by a doctor experienced in the treatment of lysosomal acid lipase deficiency, other metabolic diseases or liver diseases.
Slovenian: Zdravljenje z zdravilom Kanuma mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem pomanjkanja lizosomnega encima kisle lipaze, drugih presnovnih bolezni ali jetrnih bolezni.
English: High levels of ALT enzymes are a sign of liver damage.
Slovenian: Visoke ravni encima ALT so znak jetrne poškodbe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kanuma, 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 Kanuma in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Kanuma, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Kanuma naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: How does Kanuma work?
Slovenian: Kako zdravilo Kanuma deluje?
English: This is an inherited disease caused by the lack of an enzyme called lysosomal acid lipase, which is needed to break down fats within cells.
Slovenian: To je dedna bolezen, ki jo povzroča pomanjkanje encima, imenovanega lizosomni encim kisle lipaze, ki je potreben za razgradnjo maščob v celicah.
English: In patients who have rapidly progressing disease before 6 months of age, a dose of 1 mg/kg is given once a week instead of once every other week; in these patients the dose can be increased to 3 mg/kg once a week depending on the response to treatment.
Slovenian: Bolnikom s hitro napredujočo boleznijo pred 6 mesecem starosti se daje odmerek 1 mg/kg enkrat na teden namesto vsak drugi teden.
English: How is Kanuma used?
Slovenian: Kako se zdravilo Kanuma uporablja?
English: For the full list of all side effects reported with Kanuma, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kanuma, glejte navodilo za uporabo.
English: Kanuma contains the active substance sebelipase alfa.
Slovenian: Zdravilo Kanuma vsebuje zdravilno učinkovino sebelipaza alfa.
English: The active substance in Kanuma, sebelipase alfa, is a copy of the enzyme that is lacking in patients with lysosomal acid lipase deficiency.
Slovenian: Zdravilna učinkovina v zdravilu Kanuma, sebelipaza alfa, je kopija encima, ki ga pri bolnikih s pomanjkanjem lizosomnega encima kisle lipaze primanjkuje.
English: Kanuma has been studied in 2 main studies in patients with lysosomal acid lipase deficiency.
Slovenian: Zdravilo Kanuma so proučevali v 2 glavnih študijah pri bolnikih s pomanjkanjem lizosomnega encima kisle lipaze.
English: Kanuma is a medicine used to treat patients of all ages with lysosomal acid lipase deficiency.
Slovenian: Kanuma je zdravilo, ki se uporablja za zdravljenje bolnikov vseh starosti s pomanjkanjem lizosomnega encima kisle lipaze.
English: --1 Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 ............................................................................................................. ≥ 1 RPU* *Relative Potency Units (ELISA)
Slovenian: --1 lipoteihojska kislina (LTA) iz komponente lepljivega biofilma (Biofilm Adhesion Component - BAC) bakterije Streptococcus uberis, sev 5616 ≥ 1 RPU*
English: EU (MA) number Invente d name
Slovenian: EU (MA) številka Izmišljeno ime Jakost
English: Cattle Intramuscular Vial (glass) 1 dose (2 ml)
Slovenian: 1 odmerkom (2 ml)
English: 20 vials
Slovenian: Vialo
English: • any lumps you can see or feel.
Slovenian: • katere koli bulice, ki jih lahko vidite ali čutite.
English: Do not use force.
Slovenian: Ne uporabljajte sile.
English: Your doctor may decide to perform a physical examination.
Slovenian: Vaš zdravnik se lahko odloči opraviti telesni pregled.
English: The potential risk in humans is unknown.
Slovenian: Potencialno tveganje pri človeku ni znano.
English: “Improvement” was defined as a reduction in the severity score of 1 or more.
Slovenian: „Izboljšanje“ je bilo opredeljeno kot zmanjšanje stopnje resnosti za 1 ali več.
English: Results of the WHI studies are presented:
Slovenian: Predstavljeni so rezultati študij WHI:
English: This may include an examination of your breasts and/or an internal examination, if necessary.
Slovenian: To lahko vključuje pregled dojk in/ali notranji pregled, če je potrebno.
English: See your doctor if you notice any changes such as:
Slovenian: Obiščite zdravnika, če opazite kakršne koli spremembe, kot npr.:
English: If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy.
Slovenian: Če je od vaše zadnje menstruacije preteklo manj kot 12 mesecev ali ste mlajši od 50 let, boste za preprečevanje nosečnosti morda še vedno potrebovali dodatno kontracepcijo.
English: However, they should be considered in case of long term or repeated use of this product.
Slovenian: Treba pa jih je upoštevati pri dolgotrajni ali večkratni uporabi tega zdravila.
English: It is not known if this medicine affects fertility.
Slovenian: Ni še znano, ali to zdravilo vpliva na plodnost.
English: If you need to have surgery
Slovenian: Če potrebujete operacijo
English: • Regularly check your breasts.
Slovenian: • Svoje dojke redno pregledujte.
English: • HRT will not prevent memory loss.
Slovenian: • HNZ ne bo preprečilo izgube spomina.
English: #Overall risk ratio.
Slovenian: #Splošno razmerje tveganj.
English: The following adverse effects were also reported:
Slovenian: Poročali so tudi o naslednjih neželenih učinkih:
English: The extra risk depends on how long you take HRT.
Slovenian: Dodatno tveganje je odvisno od tega, kako dolgo jemljete HNZ.
English: B. Using the finger
Slovenian: B. Uporaba prsta
English: • migraine-like headaches which happen for the first time;
Slovenian: • migreni podobni glavoboli, ki se pojavijo prvič;
English: Therefore, if repeated, treatment should be reviewed at least annually.
Slovenian: Če bi se zdravljenje ponavljalo, ga je torej treba pregledati vsaj enkrat na leto.
English: Please talk to your doctor.
Slovenian: Prosimo, pogovorite se s svojim zdravnikom.
English: Of note, this case was present before start of treatment and was bearing a BRCA1 mutation.
Slovenian: Opozoriti je treba, da je bil ta primer prisoten pred začetkom zdravljenja in je imel mutacijo BRCA1.
English: Additionally, you are advised to join mammography screening programs when offered to you.
Slovenian: Poleg tega vam svetujemo, da se vključite v presejalne programe mamografije, ko bodo na voljo za vas.
English: It could be a sign that your endometrium has become thicker.
Slovenian: To bi lahko bil znak, da se je vaš endometrij zadebelil.
English: Endoceutics S.A. Rue Belliard 40 1040 Brussels Belgium
Slovenian: Endoceutics S.A. Rue Belliard 40 1040 Bruselj Belgija
English: • HRT use does not improve cognitive function.
Slovenian: • HNZ ne izboljša kognitivne funkcije.
English: Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Slovenian: Zdravnik si bo prizadeval, da bi za zdravljenje vaših simptomov predpisal najnižji odmerek za tako kratek čas, kot bo potrebno.
English: Reasons for immediate withdrawal of therapy
Slovenian: Razlogi za takojšnjo odtegnitev zdravljenja
English: • Hold the applicator between your thumb and middle finger.
Slovenian: • Aplikator držite med palcem in sredincem.
English: Substantial improvement Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
Slovenian: Bistveno izboljšanje Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
English: Place the applicator on a clean surface.
Slovenian: Postavite aplikator na čisto površino.
English: This happens naturally after the menopause.
Slovenian: To se po menopavzi zgodi naravno.
English: Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history.
Slovenian: Preden začnete (ali ponovno začnete) s HNZ, vas bo zdravnik vprašal o vaši lastni zdravstveni anamnezi in zdravstveni anamnezi vaše družine.
English: “Relief” was defined as no or only mild symptoms at week 12.
Slovenian: „Olajšanje“ je bilo v 12. tednu opredeljeno kot nobeno ali le blagi simptomi.
English: • If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Slovenian: • Če je prisotno katero koli od naslednjih stanj ali se je pojavilo v preteklosti in/ali močno poslabšalo v nosečnosti ali med prejšnjim hormonskim zdravljenjem, je treba bolnico skrbno nadzorovati.
English: This may relieve discomfort in the vagina.
Slovenian: To lahko zmanjša neugodje v vagini.
English: In addition, the vaginal pH decreased towards the normal range, thus facilitating the growth of the normal bacterial flora.
Slovenian: Poleg tega se vaginalni pH zniža proti normalnemu območju, kar pospešuje razrast normalne bakterijske flore.
English: Vaginal use.
Slovenian: Vaginalna uporaba.
English: • The level of risk is dependent on the duration of use (see section 4.4).
Slovenian: • Raven tveganja je odvisna od trajanja uporabe (glejte poglavje 4.4).
English: Elimination Systemic elimination has not been studied specifically for this application.
Slovenian: Izločanje Sistemsko izločanje posebej za to uporabo ni bilo proučevano.
English: • Select the position for insertion of the pessary that is most comfortable for you.
Slovenian: • Izberite položaj za vstavitev globule, ki je za vas najbolj udoben.
English: It is caused by a drop in the levels of oestrogen in your body.
Slovenian: Do tega lahko pride zaradi padca ravni estrogena v vašem telesu.
English: Conditions which need supervision
Slovenian: Stanja, ki jih je treba nadzorovati
English: • any of the conditions mentioned in the ‘DO NOT take Intrarosa' section;
Slovenian: • katero koli od bolezni, navedenih v razdelku „NE jemljite zdravila Intrarosa“;
English: Go for regular breast screening, as recommended by your doctor.
Slovenian: Pojdite na presejalne preglede dojk, kot priporoča vaš zdravnik.
English: Investigations, including Pap smears and blood pressure measurements should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Slovenian: Preiskave, vključno z brisi PAP in meritvami krvnega tlaka, je treba opravljati skladno s trenutno sprejetimi presejalnimi praksami, prilagojenimi kliničnim potrebam posameznice.
English: If so, you should see your doctor more often for check-ups:
Slovenian: Če je tako, morate pogosteje opraviti kontrolni pregled pri zdravniku:
English: • a very high level of fat in your blood (triglycerides);
Slovenian: • zelo visoko raven maščobe v krvi (trigliceridi);
English: You are now ready to insert the pessary into your vagina.
Slovenian: Zdaj ste pripravljeni, da globulo vstavite v vagino.
English: • Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Slovenian: • Predstavljeni so rezultati največjega randomiziranega s placebom kontroliranega preskušanja (študija WHI) in največje epidemiološke študije (MWS).
English: • If a pessary falls on an unsanitary surface, replace it with a new one.
Slovenian: • Če vam globula pade na nečisto površino, jo zamenjajte z drugo.
English: If you have a premature menopause the risks of using HRT may be different.
Slovenian: Če imate prezgodnjo menopavzo, so tveganja pri HNZ lahko druga.
English: Free or biological active hormone concentrations are unchanged.
Slovenian: Proste oz. biološko aktivne koncentracije hormonov se ne spremenijo.
English: Apart from the main two 12-week phase III clinical studies, the safety data of Intrarosa has also been obtained from one non comparative open-label safety study of one year.
Slovenian: Klinična varnost Poleg glavnih dveh 12-tedenskih kliničnih študij faze III so bili podatki o varnosti zdravila Intrarosa pridobljeni tudi iz ene neprimerjalne odprte varnostne študije, ki je trajala eno leto.
English: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Slovenian: Uporaba HNZ je povezana s tveganji, ki jih je treba upoštevati pri odločanju, ali naj začnete s HNZ ali s HNZ nadaljevati.
English: No studies in animals were performed with regard to the reproductive toxicity (see section 5.3).
Slovenian: Na živalih niso bile opravljene nobene študije vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Before initiating Intrarosa, a complete personal and family medical history should be taken.
Slovenian: Pred uvedbo zdravila Intrarosa je treba pridobiti popolno osebno in družinsko zdravstveno anamnezo.