FrancophonIA/ELRC3.0 huggingface dataset:
English: Adding Zynquista 200 or 400 mg to insulin led to a reduction in HbA1c levels of about 0.4 percentage points after 24 weeks of treatment, compared with almost no reduction in HbA1c levels after adding placebo to insulin.
Slovenian: Dodajanje zdravila Zynquista v jakosti 200 mg ali 400 mg insulinu je po 24 tednih zdravljenja privedlo do za približno 0,4 odstotne točke nižjihz ravni HbA1c, če pa so insulinu dodajali placebo, se raven Hb1Ac praktično ni znižala.
English: However, since Zynquista increases the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes, it is recommended only in overweight and obese patients who are expected to benefit most from treatment.
Slovenian: Ker zdravilo Zynquista pri bolnikih s sladkorno boleznijo tipa 1 precej poveča tveganje diabetične ketoacidoze, se priporoča samo pri bolnikih s prekomerno telesno maso in debelih bolnikih, pri katerih je pričakovana korist zdravljenja največja.
English: The active substance in Zynquista, sotagliflozin, blocks the action of two proteins known as glucose transporters (SGLT1 and SGLT2) which are found in the intestine and the kidneys.
Slovenian: Učinkovina v zdravilu Zynquista, sotagliflozin, zavira delovanje dveh beljakovin, ki sta znani kot prenašalca glukoze (SGLT1 in SGLT2) in sta prisotni v prebavilih in ledvicah.
English: Zynquista can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in managing type 1 diabetes.
Slovenian: Predpisovanje in izdaja zdravila Zynquista je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z obvladovanjem sladkorne bolezni tipa 1.
English: Zynquista contains the active substance sotagliflozin.
Slovenian: Zdravilo Zynquista vsebuje učinkovino sotagliflozin.
English: In type 1 diabetes, the body does not make enough insulin to control the amount of glucose (sugar) in the blood, resulting in high levels of glucose in the blood.
Slovenian: Pri sladkorni bolezni tipa 1 telo ne proizvaja dovolj insulina za uravnavanje količine glukoze (sladkorja) v krvi, kar privede do visokih ravni glukoze v krvi.
English: Zynquista, taken together with insulin, is effective in lowering blood glucose levels in patients with type 1 diabetes whose blood sugar is not controlled well enough with insulin alone.
Slovenian: Zdravilo Zynquista, ki se jemlje hkrati z insulinom, je učinkovito pri zniževanju ravni glukoze v krvi pri bolnikih s sladkorno boleznijo tipa 1, pri katerih sladkor v krvi samo z insulinom ni dovolj dobro uravnan.
English: Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes.
Slovenian: Zynquista je zdravilo za zdravljenje sladkorne bolezni, ki se skupaj z insulinom uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 1.
English: For the full list of side effects and restrictions with Zynquista, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zynquista glejte navodilo za uporabo.
English: In addition, patients treated with the medicine have beneficial reductions in weight and blood pressure.
Slovenian: Poleg tega so koristni učinki pri bolnikih, zdravljenih s tem zdravilom, tudi zmanjšanje telesne mase in znižanje krvnega tlaka.
English: How is Zynquista used?
Slovenian: Kako se zdravilo Zynquista uporablja?
English: How does Zynquista work?
Slovenian: Kako zdravilo Zynquista deluje?
English: As result, sotagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Slovenian: Tako povzroči, da ledvice v urin izločijo več glukoze, kar zniža ravni glukoze v krvi.
English: By blocking SGLT1 in the intestine, sotagliflozin delays the absorption of glucose into the blood after a meal.
Slovenian: Sotagliflozin z zaviranjem beljakovine SGLT1 v prebavilih upočasni absorpcijo glukoze v kri po obroku.
English: In the kidneys, sotagliflozin blocks SGLT2 involved in stopping glucose in the bloodstream from being passed out into the urine.
Slovenian: Sotagliflozin v ledvicah zavira beljakovino SGLT2, ki ustavlja prehod glukoze iz krvnega obtoka v urin.
English: Zynquista was found effective at controlling blood glucose levels in 3 main studies in patients with type 1 diabetes.
Slovenian: V treh glavnih študijah pri bolnikih s sladkorno boleznijo tipa 1 so ugotovili, da je zdravilo Zynquista učinkovito pri uravnavanju ravni glukoze v krvi.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1021/001 Pregabalin Zentiva 25 mg Capsule, hard
Slovenian: 56 kapsul s
English: Submission of final clinical study report by 31 March 2025
Slovenian: Predložitev končnega poročila klinične študije do 31. marca 2025
English: Date of first authorisation: 20 August 2015
Slovenian: Datum prve odobritve: 20. avgust 2015
English: * n=18 subjects.
Slovenian: * n = 18 oseb.
English: He or she will take the appropriate measures.
Slovenian: Ustrezno bo ukrepal.
English: Maximum concentration (Cmax)
Slovenian: Največja koncentracija (Cmax)
English: Because of this damage, the lungs do not work properly.
Slovenian: Zaradi te poškodbe pljuča ne delajo pravilno.
English: Free elastase was immeasurably low in all samples.
Slovenian: Prosta elastaza je bila v vseh vzorcih neizmerno nizka.
English: In some cases severe allergic reactions may occur.
Slovenian: V nekaterih primerih se lahko pojavijo hude alergijske reakcije.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: The population estimate of mean half-life was 6.8 days.
Slovenian: Ocenjena povprečna razpolovna doba za populacijo je bila 6,8 dni.
English: Mean (standard deviation)*
Slovenian: Povprečje (standardni odklon)*
English: The subjects ranged in age from 29 to 68 years (median age 49 years).
Slovenian: Starost oseb je bila od 29 do 68 let (mediana starost 49 let).
English: This medicine is not for use in children or adolescents below 18years of age.
Slovenian: Tega zdravila ne smejo uporabljati otroci in mladostniki, stari manj kot 18let.
English: The frequency of ARs during post marketing only is considered as “not known (cannot be estimated from the available data)”.
Slovenian: Pogostnost neželenih učinkov iz obdobja trženja je ocenjena kot "neznana (ni mogoče oceniti iz razpoložljivih podatkov)".
English: No alternative dose regimen can be recommended in those patients.
Slovenian: Za te bolnike ni mogoče priporočati alternativnega režima odmerjanja.
English: • Do not use provided sterile ancillaries for reconstitution if their package is opened or if they are damaged.
Slovenian: • Ne uporabljajte priloženih sterilnih pripomočkov za rekonstitucijo, če je njihov paket odprt ali so poškodovani.
English: The other side effects may include:
Slovenian: Drugi neželeni učinki lahko vključujejo:
English: • The reconstitution should be performed according to the instructions provided below.
Slovenian: • Rekonstitucijo je treba opraviti v skladu s spodaj navedenimi navodili.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Slovenian: Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po rekonstituciji.
English: Therefore cessation of smoking and the avoidance of environmental tobacco smoke are strongly recommended.
Slovenian: Zato se močno priporoča prenehanje kajenja in izogibanje okolju s tobačnim dimom.
English: If you are breast-feeding, your doctor will discuss with you the risks and benefits of taking this medicine.
Slovenian: Če dojite, se bo zdravnik z vami pogovoril o tveganjih in koristih uporabe tega zdravila.
English: 603 (±129) mL/day
Slovenian: 603 (± 129) ml/dan
English: Terminal half-life (t1/2ß)
Slovenian: Končna razpolovna doba (t1/2ß)
English: • how to keep the product sterile (aseptic infusion techniques)
Slovenian: • kako ohranjati sterilnost zdravila (aseptične tehnike infundiranja),
English: Information on safety with respect to infections
Slovenian: Informacije o varnosti vzvezi z okužbami
English: • The product must be reconstituted, administered and handled with caution using aseptic technique to maintain product sterility.
Slovenian: • Zdravilo je treba rekonstituirati, aplicirati in z njim ravnati previdno, z uporabo aseptične tehnike, da se ohrani sterilnost zdravila.
English: • how to keep a treatment diary
Slovenian: • kako voditi dnevnik zdravljenja,
English: Patients should be informed of signs of hypersensitivity reactions.
Slovenian: Bolnike je treba opozoriti na znake preobčutljivostnih reakcij.
English: Repeat dose toxicity studies longer than 5 days, reproductive toxicity studies and carcinogenicity studies, have not been performed.
Slovenian: Študij toksičnosti pri ponavljajočem odmerku, daljših od 5 dni, študij reproduktivne toksičnosti in študij kancerogenosti niso izvedli.
English: Tobacco smoke is an important risk factor for the development and progression of emphysema.
Slovenian: Kajenje tobaka je pomemben dejavnik tveganja za razvoj in napredovanje emfizema.
English: • With one hand tightly grasp the Respreeza vial as shown in Figure 5.
Slovenian: • Z eno roko močno primite vialo z zdravilom Respreeza kot je prikazano na sliki 5.
English: Such studies are not considered meaningful due to the production of antibodies against the heterologous human protein in animals.
Slovenian: Take študije se ne zdijo smiselne zaradi nastajanja protiteles proti heterolognim človeškim beljakovinam pri živalih.
English: Do not use solutions that are discoloured, cloudy or have particles.
Slovenian: Ne uporabljajte raztopin, ki so obarvane, motne ali imajo delce.
English: Respreeza is made from human blood plasma (this is the liquid part of the blood with the blood cells removed).
Slovenian: Zdravilo Respreeza je narejeno iz človeške krvne plazme (to je tekoči del krvi z odstranjenimi krvnimi celicami).
English: The safety of Respreeza has been assessed in several preclinical studies.
Slovenian: Varnost zdravila Respreeza je bila ovrednotena v več predkliničnih študijah.
English: Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Slovenian: Zato ima lahko zdravilo Respreeza blag vpliv na sposobnost vožnje in upravljanja strojev.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali zdravstvenim delavcem, preden vzamete to zdravilo.
English: If your doctor decides that you are suitable for such home-treatment / selfadministration, he or she will instruct you in:
Slovenian: Če se zdravnik odloči, da ste primerni za zdravljenje doma/samoinfundiranje, vas bo poučil glede naslednjega:
English: One vial of Respreeza is for single use only.
Slovenian: Ena viala zdravila Respreeza je samo za enkratno uporabo.
English: If more than 1 vial of Respreeza is needed to achieve the required dose, repeat instructions 1 to 11 above using an additional package containing an unused Mix2Vial set.
Slovenian: Če boste za potrebni odmerek potrebovali več kot 1 vialo zdravila Respreeza, ponovite zgornja navodila od 1 do 11 z dodatnim pakiranjem, ki vsebuje neuporabljen komplet Mix2Vial.
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveznosti izvedbe ukrepov po pridobitvi dovoljenja za promet
English: If you experience dizziness, you should not drive or use machines until the dizziness has passed (see section 4).
Slovenian: Če se pojavi omotica, ne vozite ali upravljajte strojev, dokler omotica ne mine (glejte poglavje 4).
English: Since tobacco smoke is an important risk factor for the development and progression of emphysema, you are strongly advised to stop smoking and avoid passive smoking.
Slovenian: Ker je kajenje tobaka pomemben dejavnik tveganja za razvoj in napredovanje emfizema, vam močno priporočamo, da nehate kaditi in se izogibate pasivnemu kajenju.
English: In case of shock, emergency medical treatment should be administered.
Slovenian: Pri šoku je treba uvesti nujno zdravljenje.
English: Proceed with your next dose immediately and continue at regular intervals as advised by your doctor or healthcare professional.
Slovenian: Takoj nadaljujte z naslednjim odmerkom, nato pa nadaljujte v rednih intervalih, kot vam je svetoval zdravnik ali zdravstveni delavec.
English: The amount of Respreeza you are given is based on your body weight.
Slovenian: Količina zdravila Respreeza, ki jo boste prejeli, je odvisna od vaše telesne mase.
English: •how to prepare and givethis medicine (see the illustrated instructions at the end of this leaflet in
Slovenian: •kako pripraviti in dajati to zdravilo (glejte navodila z risbami na koncu tega navodila v
English: If this is not possible, solutions can be stored up to 3 hours at room temperature (up to 25 °C).
Slovenian: Če to ni mogoče, lahko raztopino do 3 ure shranjujete pri sobni temperaturi (do 25°C).
English: The recommended infusion rate given under section 4.2 should be adhered.
Slovenian: Upoštevati je treba hitrost infundiranja, priporočeno v poglavju 4.2.
English: Conditions that increase neutrophil accumulation and activation in the lung, such as respiratory infection and smoking, will in turn increase levels of NE.
Slovenian: Pogoji, ki povečajo kopičenje in aktiviranje nevtrofilcev v pljučih, kot sta okužba dihal in kajenje, povečajo raven NE.
English: Take care not to touch the rubber vial stopper.
Slovenian: Pazite, da se ne dotaknete gumijastega zamaška viale.
English: If treatment with Respreeza is stopped, your condition may worsen.
Slovenian: Če se prenehate zdraviti z zdravilom Respreeza, se lahko stanje poslabša.
English: • if you have been found to have a deficiency of certain blood proteins called immunoglobulin type A (IgA) and have developed antibodies against them.
Slovenian: • če je bilo ugotovljeno, da imate pomanjkanje določene krvne beljakovine, imenovane imunoglobulin tipa (IgA) in so se pri vas razvila protitelesa proti njim.
English: However, Respreeza should be given with caution to pregnant women.
Slovenian: Kljub temu je treba zdravilo Respreeza nosečnicam dajati previdno.
English: This leaflet was last revised in MM/YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL
English: Consequences of overdose are unknown.
Slovenian: Posledice prevelikega odmerjanja niso znane.
English: What you need to know before you use Respreeza 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Respreeza 3.
English: Pediatric population
Slovenian: Pediatrična populacija
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte tudi poglavje 4.4).
English: For detailed information regarding the administration of the reconstituted solution, see the instructions at the end of section 6.6.
Slovenian: Za podrobne informacije glede dajanja rekonstituirane raztopine glejte navodila na koncu poglavja 6.6.
English: In the event of overdose, the patient should be observed closely for the occurrence of adverse reactions and supportive measures should be available as necessary.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika skrbno opazovati zaradi pojava neželenih učinkov; na voljo morajo biti ustrezni podporni ukrepi.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation / removal of viruses.
Slovenian: Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe in vključevanje učinkovitih proizvodnih korakov za inaktivacijo/odstranitev virusov.
English: Information on allergic reactions: when slowing or stopping the infusion may be required?
Slovenian: Informacije o alergijskih reakcijah: kdaj bo morda treba infundiranje upočasniti ali ustaviti?
English: Hypersensitivity or allergic reactions have been observed during the treatment.
Slovenian: Med zdravljenjem so opazili preobčutljivostne ali alergijske reakcije.
English: Table 1 shows the mean results for the Respreeza pharmacokinetic parameters.
Slovenian: V preglednici 1 so prikazani povprečni rezultati za farmakokinetične parametre zdravila Respreeza.
English: 144 (±27) µM x day
Slovenian: 144 (± 27) µM x dan
English: 6.5 Nature and contents of container and special equipment for administration
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za dajanje
English: Other medicines and Respreeza
Slovenian: Druga zdravila in zdravilo Respreeza
English: “Information for health-care professionals and for patients suitable for home-treatment / self administration”)
Slovenian: "Informacije za zdravstvene delavce in bolnike, ki so primerni za zdravljenje doma/samoinfundiranje"),
English: A population pharmacokinetic analysis was conducted using data from 90 Respreeza-treated subjects from the RAPID trial.
Slovenian: Analiza populacijske farmakokinetike je bila izvedena s podatki 90 oseb, zdravljenih z zdravilom Respreeza, iz preskušanja RAPID.
English: • The powder must be reconstituted with solvent (water for injections).
Slovenian: • Prašek je treba rekonstituirati z vehiklom (voda za injekcije).
English: The safety and efficacy of Respreeza was evaluated in a randomized, double-blind, placebocontrolled, multi-center study (RAPID) followed by a 2-year open-label extension study (RAPID extension study).
Slovenian: Varnost in učinkovitost zdravila Respreeza so ocenili v randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji (RAPID), ki ji je sledil 2-letni odprt podaljšek študije (podaljšek študije RAPID).
English: A total of 13 post-infusion serum samples were taken at various time points up to Day 21.
Slovenian: Do 21. dne je bilo odvzetih skupaj 13 vzorcev seruma po infundiranju ob različnih časovnih točkah.
English: However, as there is no information available regarding the safety of Respreeza use during pregnancy, if you are pregnant, this medicine should only be given to you with caution.
Slovenian: Vendar pa informacij o varnosti uporabe zdravila Respreeza med nosečnostjo ni, zato vam morajo to zdravilo, če ste noseči, dajati previdno.
English: Frequency per patient (based on six months of exposure during clinical trials) has been evaluated according to the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Slovenian: Pogostnost na bolnika (na podlagi šestmesečne izpostavljenosti med kliničnimi preskušanji) je bila ocenjena po naslednjem dogovoru: pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (1/10.000 do <1/1.000) in zelo redki (<1/10.000).
English: What Respreeza is and what it is used for 2.
Slovenian: Kaj je zdravilo Respreeza in za kaj ga uporabljamo 2.
English: The water for injections will automatically flow into the Respreeza vial.
Slovenian: Voda za injekcije bo samodejno stekla v vialo z zdravilom Respreeza.
English: The reconstituted solution has an approximate osmolality of 279 mOsmol / kg and a pH of 7.0.
Slovenian: Rekonstituirana raztopina ima približno osmolalnost 279 mOsmol/kg in pH 7,0.
English: If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.
Slovenian: Če se simptomi kmalu po prenehanju dajanja poležejo, se lahko z infundiranjem nadaljuje z manjšo hitrostjo, ki je za bolnika ugodna.
English: Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitor, ATC code: B02AB02
Slovenian: Farmakoterapevtska skupina: antihemoragiki, zaviralci proteinaz, oznaka ATC: B02AB02
English: In the most serious cases, allergic reactions may progress to severe anaphylactic reactions even when the patient has shown no hypersensitivity to previous administrations (see section 4.4).
Slovenian: V najresnejših primerih lahko alergijske reakcije napredujejo do hudih anafilaktičnih reakcij, čeprav bolnik ni bil preobčutljiv na predhodna dajanja (glejte poglavje 4.4).
English: They may progress in some very rare cases (may affect up to 1 in 10,000 people) to severe allergic reactions even when you have shown no signs of allergy on previous infusions.
Slovenian: V nekaterih zelo redkih primerih lahko napredujejo (pojavijo se lahko pri največ 1 od 10.000 bolnikov) do hudih alergijskih reakcij, čeprav pri prejšnjem infundiranju niste kazali nobenih znakov alergije.
English: 5.1 (±2.4) days
Slovenian: 5,1 (± 2,4) dni
English: • the testing of samples of donated blood and plasma to try to avoid use of material with signs of virus/infections,
Slovenian: • testiranje vzorcev darovane krvi in plazme, da se poskusi preprečiti uporaba materialov z znaki virusov/okužb,
English: NOTE: Ensure all water has transferred into the Respreeza vial.
Slovenian: OPOMBA: Poskrbite, da se je vsa voda prenesla v vialo z zdravilom Respreeza.
English: Your doctor or healthcare professional will take that into consideration if you are on a controlled sodium diet.
Slovenian: Zdravnik ali zdravstveni delavec bo to upošteval, če ste na dieti z nadziranim vnosom natrija.
English: Home treatment / Self-administration
Slovenian: Zdravljenje doma/samoinfundiranje
English: However chemical and physical in-use stability has been demonstrated for 3 h at room temperature (up to 25 °C).
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 3 ure pri sobni temperaturi (do 25 °C).
English: The powder must be reconstituted with water for injections (see instructions on reconstitution in section°6.6) and administered using an intravenous administration set (not supplied).
Slovenian: Prašek je treba rekonstituirati z vodo za injekcije (glejte navodila za rekonstitucijo v poglavju 6.6) in aplicirati z intravenskim priborom (ni priloženo).
English: If you forget to use Respreeza
Slovenian: Če ste pozabili uporabiti zdravilo Respreeza
English: There, its main function is to protect the lung tissue by limiting the action of a certain enzyme, called neutrophil elastase.
Slovenian: Tam je njegova glavna funkcija zaščita pljučnega tkiva z omejevanjem delovanja določenega encima, imenovanega nevtrofilna elastaza.
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived proteinase inhibitors.
Slovenian: Zdravnik vam bo morda priporočil cepljenje proti virusom hepatitisa A in B, če redno/večkrat prejemate humane zaviralce proteinaze, pridobljene iz človeške plazme.
English: RAPID studies
Slovenian: Študiji RAPID
English: Total clearance
Slovenian: Skupni očistek
English: Inject/infuse the reconstituted solution into the vein following the instructions given to you by your doctor.
Slovenian: Rekonstituirano raztopino si injicirajte/infundirajte v veno po navodilih, ki ste jih prejeli od zdravnika.
English: Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Slovenian: Bolniki s selektivnim ali hudim pomanjkanjem IgA lahko razvijejo protitelesa proti IgA in imajo zato večje tveganje za razvoj potencialno hude preobčutljivosti in anafilaktičnih reakcij.
English: There are limited data regarding the use of this medicinal product in home-treatment / selfadministration.
Slovenian: Podatki o uporabi tega zdravila pri zdravljenju doma/samoinfundiranju so omejeni.