FrancophonIA/ELRC3.0 huggingface dataset:
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Accord powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Accord.
English: Posology for previously untreated multiple myeloma patients eligible for haematopoietic stem cell transplantation (induction therapy)
Slovenian: Priporočeno odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in so primerni za presaditev krvotvornih matičnih celic (uvajalno zdravljenje)
English: *CR+nCR
Slovenian: *RR (po presaditvi) CR+nCR
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Slovenian: omotica*, disgevzija*, letargija, glavobol*
English: Antiviral prophylaxis was administered to 26% of the patients in the Bz+M+P arm.
Slovenian: V Bz+M+P kraku študije je protivirusna zdravila prejelo 26% bolnikov.
English: However, the chemical and physical in-use stability has been demonstrated for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Slovenian: Zdravilo je kemično in fizikalno stabilno 8 ur pri temperaturi do 25°C, če ga pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
English: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Slovenian: Klinična učinkovitost zdravila pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic
English: If you are given Bortezomib Accord for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Slovenian: - mišični krči, mišična šibkost - zmedenost, izguba ali motnje vida, slepota, epileptični napadi, glavoboli - težko dihanje, otekanje nog ali spremembe srčnega utripa, visok krvni tlak, utrujenost,
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Slovenian: Biotransformacija Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) 1,659 l do 3294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
English: (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
Slovenian: - krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih).
English: d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
Slovenian: * CR+PR+MR; **CR=CR, (IF-); nCR=CR (IF+)
English: Twice weekly Bortezomib Accord (cycles 1-4) Week Bz (1.3 mg/m
Slovenian: Odmerjanje zdravila Bortezomib Accord dvakrat na teden (krogi 1-4)
English: PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Slovenian: Pri bolnikih, ki so prejemali bortezomib, so poročali o PRES. PRES je redka, pogosto reverzibilna nevrološka motnja, ki se razvije hitro in se lahko kaže z epileptičnimi napadi, hipertenzijo, glavoboli,
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Slovenian: Na voljo so le omejeni podatki o ponovnem zdravljenju z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Slovenian: Bolnike, ki so predhodno imeli vsaj delni odgovor na režim zdravljenja z bortezomibom so ponovno zdravili po napredovanju bolezni.
English: • Hormone abnormality which may affect salt and water absorption
Slovenian: • poslabšanje sluha, gluhost ali zvonjenje v ušesih, nelagodje v ušesu • hormonske motnje, ki lahko vplivajo na absorpcijo soli in vode
English: Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Slovenian: Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na dan 1, 4, 8 in 11 v 28 dnevnem krogu zdravljenja.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Slovenian: Med zdravljenjem z bortezomibom se zelo pogosto pojavijo toksični učinki na prebavila, kot so slabost, driska, bruhanje in zaprtje.
English: • Hernia
Slovenian: OVOJNINAH
English: This medicine is for intravenous or subcutaneous use.
Slovenian: To zdravilo se daje samo intravensko.
English: Severity of neuropathy
Slovenian: Stopnja nevropatije
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Slovenian: CR=popolni odgovor; CRu=nepotrjen popšolni odgovor; PR=delni odgovor; CI=interval zaupanja, HR=razmerje tveganja; OR=razmerje verjetnosti; ITT=populacija, ki so jo nameravali zdraviti
English: • If local injection site reactions occur following Bortezomib Accord injection subcutaneously, either a less concentrated Bortezomib Accord solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Slovenian: • Če se po subkutanem injiciranju zdravila Bortezomib Accord na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
Slovenian: (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ali inotropne učinkovine) in telesne temperature
English: Oedema (inc peripheral), Chills, Pain*, Malaise*
Slovenian: Pogosti dispneja*, kašelj*, kolcanje
English: Bortezomib Accord powder has to be dissolved before administration.
Slovenian: Bortezomib Accord mora preteči najmanj 72 ur.
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Constipation Common
Slovenian: Zelo pogosti bolezni las* Pogosti srbenje*, dermatitis*, izpuščaj*
English: A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction
Slovenian: V farmakokinetični študiji varnosti in učinkovitosti faze II, z enim krakom, ki jo je izvedla Skupina za otroško onkologijo (COG - Children's Oncology Group), so ocenili delovanje bortezomiba, ki so ga dodali k ponovno uvedeni indukcijski kemoterapiji z več zdravili pri pediatričnih in mladih odraslih bolnikih z limfatičnimi malignomi (s pre-B-celično akutno limfoblastno levkemijo [ALL], T-celično ALL in T-celičnim limfoblastnim limfomom [LL]).
English: Table 4: Posology for Bortezomib Accord combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Slovenian: Preglednica 4: Priporočeno odmerjanje zdravila Bortezomib Accord pri bolnikih, s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev hematopoetskih matičnih celic primerna.
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BzR-CAP arm and 61% of patients in the R-CHOP arm.
Slovenian: 78% bolnikov v skupini BzR-CAP in 61% bolnikov v skupini R-CHOP.
English: Median duration Days (months) Time to response CR+PR (days)
Slovenian: CR + PR (dnevi)
English: • If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Slovenian: • Pri bolnikih z infiltracijo kostnega mozga ali sekvestracijo vranice mora biti število trombocitov
English: SC or IV
Slovenian: S. k. ali i.v.
English: • In cycles 5 to 9, Bortezomib Accord is administered once weekly on days 1, 8, 22 and 29.
Slovenian: 1., 4., 8., 11., 22., 25., 29. in 32. dan. - V krogih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
English: • If platelet counts < 25,000 cells/μL.
Slovenian: < 25.000 celic/μl ali ANC < 750 celic/μl.
English: Bortezomib Accord is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Slovenian: Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21 dnevnem krogu zdravljenja.
English: Muscle twitching, Joint swelling, Arthritis*, Joint stiffness, Myopathies*,Sensation of heaviness
Slovenian: Občasni trzanje mišic, otekanje sklepov, artritis*, okorelost sklepov,
English: Day rest period rest period
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Slovenian: Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja
English: Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention Uncommon Tumour lysis syndrome
Slovenian: hipernatriemija*, nenormalne koncentracije sečne kisline*, sladkorna bolezen*, zastajanje tekočine
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Slovenian: izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema, vezivnega tkiva*, sinovialna cista
English: tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Slovenian: oteženo ali preneha, sopenje • kolcanje, motnje govora
English: Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Slovenian: Ocena po metodi Kaplan-Meier.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E 421)
English: • Multi-organ failure
Slovenian: • izguba telesne mase
English: ≥ 25,000 cells/μL, Bortezomib Accord may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).
Slovenian: • Če toksičnost mine oz. ima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl, lahko ponovno uvedete zdravilo Bortezomib Accord v odmerku, ki je eno stopnjo nižji od prejšnjega(z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na
English: Very Common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Slovenian: Zelo pogosti trombocitopenija*, nevtropenija*, anemija* Pogosti levkopenija*, limfopenija*
English: Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Slovenian: srčno-žilne bolezni (vključno s kardiogenim šokom), Torsade de pointes, nestabilna angina pektoris, bolezni srčnih zaklopk*,
English: • If toxicity resolves i.e. patient has an
Slovenian: • Če je na dan odmerjanja zdravila
English: Day 22
Slovenian: 27 mesecev
English: Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia*
Slovenian: levkocitoza*, limfadenopatija, hemolitična anemija#
English: breathing that becomes shallow, difficult or stops, wheezing
Slovenian: oteženo ali preneha, sopenje.
English: Cardiac disorders Uncommon
Slovenian: Organski sistem Pogostnost Neželeni učinek
English: Nine treatment cycles of this combination therapy are administered.
Slovenian: Zdravljenje z zdravilom Bortezomib Accord traja devet krogov.
English: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury
Slovenian: - belih krvnih celic in tako bolj dovzetni za okužbe ali gripi podobne simptome.
English: • Alteration of liver function
Slovenian: • zvišana telesna temperatura
English: Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
Slovenian: sindrom kašlja zgornjih dihalnih poti (UACS - Upper-airway cough syndrome) Bolezni prebavil Zelo pogosti simptomi navzee in bruhanja*, driska*, zaprtje Pogosti krvavitev v prebavilih (vključno s sluznico)*, dispepsija, stomatitis*, napetost v trebuhu, bolečina v žrelu in grlu*, bolečina v trebuhu (vključno z bolečino v prebavilih in vranici)*, bolezni ust*, flatulenca
English: • Genital pain, problem having an erection
Slovenian: • vnetje trebušne slinavke, zapora žolčevoda • bolečina v spolovilih, motnje pri doseganju erekcije
English: If local injection site reactions occur following Bortezomib Accord subcutaneous injection, either a less concentrated Bortezomib Accord solution (Bortezomib Accord 3.5 mg to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Slovenian: Bortezomib Accord (1 mg/ml namesto 2,5 mg/ml) ali pa preidete na intravensko dajanje zdravila.
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Slovenian: Zelo pogosti zvišana telesna temperatura*, izčrpanost, astenija
English: Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness) Cardiac disorders Common
Slovenian: Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
English: T 200 mg a
Slovenian: T 200 mga na dan na dan na dan na dan
English: The exact mechanism of this interaction is not clear.
Slovenian: Natančen mehanizem te interakcije ni jasen.
English: This may happen:
Slovenian: To se lahko zgodi, če:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 June 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 29. junij 2009
English: Date of latest renewal: 19 June 2014
Slovenian: Datum zadnjega podaljšanja: 19. junij 2014
English: Talk to your doctor if any of the above applies to you.
Slovenian: Obvestite svojega zdravnika, če kar koli od naštetega velja za vas.
English: Your diabetes may get worse.
Slovenian: Sladkorna bolezen se vam lahko poslabša.
English: Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Slovenian: Madžarska (Headquarters: 4042 Debrecen, Pallagi út 13)
English: Repaglinide has no direct influence on the ability to drive and use machines but may cause hypoglycaemia.
Slovenian: Zdravilo Repaglinid nima neposrednega vpliva na sposobnost vožnje in upravljanja s stroji, vendar pa lahko povzroči hipoglikemijo.
English: The amount of Repaglinide Teva, food or exercise may need to be adjusted.
Slovenian: Morda bo treba prilagoditi količino zdravila Repaglinid Teva, hrano ali telesno dejavnost.
English: Repaglinide has been given with weekly escalating doses from 4 - 20 mg four times daily in a 6 week period.
Slovenian: Repaglinid so dajali v tedensko naraščajočih odmerkih od 4 - 20 mg štirikrat na dan 6 tednov.
English: Your ability to drive or use a machine may be affected if your blood sugar is low or high.
Slovenian: Vaša sposobnost za vožnjo ali upravljanje s stroji se lahko spremeni, če je vaš sladkor v krvi previsok ali prenizek.
English: If you forget to take Repaglinide Teva If you miss a dose, take the next dose as usual - do not double the dose.
Slovenian: Če ste pozabili vzeti zdravilo Repaglinid Teva Če izpustite odmerek, vzemite naslednji odmerek kot ponavadi - ne podvajajte odmerka.
English: Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Slovenian: Na podlagi izkušenj z repaglinidom in drugimi antidiabetiki so bili ugotovljeni naslednji neželeni učinki: opredelitev pogostnosti je: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Your body's response to Repaglinide Teva may change if you take other medicines, especially these:
Slovenian: Vaš odziv na zdravilo Repaglinid Teva se lahko spremeni, če jemljete še druga zdravila, še posebno:
English: • Diabetes mellitus type 1, C-peptide negative.
Slovenian: • Sladkorna bolezen tipa 1 (negativni C-peptid).
English: If any change of your treatment is necessary contact your doctor first.
Slovenian: Če je potrebna kakršna koli sprememba zdravljenja, se najprej posvetujte z zdravnikom.
English: Rare (may affect up to 1 in 1,000 patients) • Acute coronary syndrome (but it may not be due to the medicine).
Slovenian: Redki (pojavijo se lahko pri največ 1 od 100 bolnikov) • akutni koronarni sindrom (ki pa lahko ni posledica zdravila)
English: Repaglinide Teva may not be suitable for you.
Slovenian: Zdravilo Repaglinid Teva za vas morda ni primerno.
English: You should not take Repaglinide Teva if you are pregnant or you are planning to become pregnant.
Slovenian: Ne jemljite zdravila Repaglinid Teva, če ste noseči ali nameravate zanositi.
English: • Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost za repaglinid ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: Please ask your doctor whether you can drive a car if you:
Slovenian: Posvetujte se z zdravnikom, ali naj sploh vozite ali upravljate s stroji, če:
English: In this case, the dosage of metformin should be maintained and repaglinide administered concomitantly.
Slovenian: V tem primeru je treba odmerjanje metformina ohraniti in sočasno uporabiti repaglinid.
English: This may be due to progression of the severity of the diabetes or to diminished responsiveness to the medicinal product.
Slovenian: To je morda posledica napredovanja sladkorne bolezni ali zmanjšane odzivnosti na zdravilo.
English: When repaglinide is used together with other medicinal products that are mainly secreted by the bile, like repaglinide, any potential interaction should be considered.
Slovenian: Če se repaglinid uporablja z drugimi zdravili, ki se izločajo predvsem v žolču, tako kot repaglinid, je treba upoštevati morebitne interakcije.
English: Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%).
Slovenian: Za farmakokinetiko repaglinida so značilni 63% povprečna absolutna biološka uporabnost (CV 11%).
English: Consequently metabolism, and by that clearance of repaglinide, may be altered by substances which influence these cytochrome P-450 enzymes via inhibition or induction.
Slovenian: Zato se presnova in s tem tudi očistek repaglinida lahko spremenita zaradi učinkovin, ki vplivajo na te citokrom P-450 encime bodisi z inhibicijo ali indukcijo.
English: • If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section 6).
Slovenian: • če ste alergični na repaglinid ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
Slovenian: Na podlagi podatkov in vitro kaže, da je repaglinid substrat aktivnega prevzema v jetrih (transportna beljakovina organskih anionov OATP1B1).
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Slovenian: To je posebno pomembno pri bolnikih z zmanjšanim ali odsotnim zaznavanjem opozorilnih znakov hipoglikemije in pri tistih, ki imajo pogoste hipoglikemije.
English: Substances that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
Slovenian: Učinkovine, ki zavirajo OATP1B1, lahko morda koncentracijo repaglinida v plazmi zvišajo podobno, kot je ugotovljeno za ciklosporin (glejte spodaj).
English: As hypoglycaemia in this study was avoided through increased calorie intake, a relative overdose may result in an exaggerated glucose-lowering effect with development of hypoglycaemic symptoms (dizziness, sweating, tremor, headache etc.).
Slovenian: Ker so se hipoglikemiji v tej študiji izognili z večjim kaloričnim vnosom, lahko relativno preveliko odmerjanje povzroči čezmerno znižanje glukoze in pojav simptomov hipoglikemije (omotica, znojenje, tremor, glavobol itn.).
English: Do not take more Repaglinide Teva than your doctor has recommended.
Slovenian: Ne vzemite več zdravila Repaglinid Teva, kot vam je svetoval zdravnik.
English: Do not use this medicine after the expiry date which is stated on the carton and blister foil after EXP.
Slovenian: Tega zdravila Repaglinid Teva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »EXP«.
English: Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness (i.e. secondary failure).
Slovenian: Redno spremljanje je potrebno, da bi odkrili nezadostno znižanje glukoze v krvi ob priporočenem največjem odmerku (tj. primarno odpoved), ali nezadostno znižanje glukoze po uvodnem obdobju učinkovitosti (tj. sekundarno odpoved).
English: They include: increased urination; feeling thirsty; dry skin and dry mouth.
Slovenian: povečano uriniranje, občutek žeje, suha koža in suha usta.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Slovenian: Bolnikom je treba svetovati, naj upoštevajo varnostne ukrepe, da bi preprečili hipoglikemijo med upravljanjem vozila.
English: This phenomenon is known as secondary failure, to distinguish it from primary failure, where the medicinal product is ineffective in an individual patient when first given.
Slovenian: Pojav je poznan kot sekundarna odpoved, za razliko od primarne odpovedi, pri kateri je zdravilo neučinkovito, že ko ga posameznik dobi prvič.
English: Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Slovenian: Uporaba repaglinida v primerih sekundarne odpovedi sekretagogov insulina ni bila raziskana v kliničnih preskušanjih.
English: There are no studies of repaglinide in pregnant women.
Slovenian: Študij o uporabi repaglinida pri nosečnicah ni.
English: Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler Germany
Slovenian: Merckle GmbH Ludwig-Merckle-Straße 3, 89143 Blaubeuren-Weiler