FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da med zdraviloma Thorinane in Clexane ni klinično pomembnih razlik v učinkovitosti ali varnosti, in menil, da enako kot pri zdravilu Clexane koristi odtehtajo znana tveganja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thorinane 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 Thorinane upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Thorinane enoxaparin sodium
Slovenian: Thorinane natrijev enoksaparinat
English: The Committee recommended that Thorinane be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Thorinane izda dovoljenje za promet.
English: For more information about treatment with Thorinane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Thorinane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Thorinane must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke.
Slovenian: Zdravilo Thorinane se ne sme uporabljati pri bolnikih z večjimi krvavitvami, hudimi motnjami strjevanja krvi ali boleznimi, pri katerih se lahko poveča tveganje za krvavitve ali zaradi njih, kot so želodčne razjede ali kap.
English: What are the risks associated with Thorinane?
Slovenian: Kakšna tveganja so povezana z zdravilom Thorinane?
English: The most common side effect with Thorinane (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Thorinane to prevent blood clots during surgery.
Slovenian: Najpogostejši neželeni učinek zdravila Thorinane (ki se lahko pojavi pri več kot 1 bolniku od 10) je krvavitev; resna krvavitev se je pojavila pri približno štirih bolnikih od 100, ki so zdravilo Thorinane prejeli za preprečevanje krvnih strdkov med kirurškim posegom.
English: What is Thorinane and what is it used for?
Slovenian: Kaj je zdravilo Thorinane in za kaj se uporablja?
English: Why is Thorinane approved?
Slovenian: Zakaj je bilo zdravilo Thorinane odobreno?
English: What benefits of Thorinane have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Thorinane izkazalo v študijah?
English: Thorinane is an anticoagulant medicine (a medicine to prevent blood clots).
Slovenian: Thorinane je antikoagulacijsko zdravilo (zdravilo za preprečevanje krvnih strdkov).
English: For practical information about using Thorinane, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Thorinane naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In the treatment of unstable angina and heart attack Thorinane is given with aspirin (acetylsalicylic acid).
Slovenian: Pri zdravljenju nestabilne angine pektoris in srčne kapi se zdravilo Thorinane daje v kombinaciji z aspirinom (acetilsalicilno kislino).
English: Studies have shown that Thorinane has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors.
Slovenian: Študije so pokazale, da ima zdravilo Thorinane zelo podobno zgradbo in biološko aktivnost kot zdravilo Clexane ter enak učinek na faktorje strjevanja krvi.
English: In addition, a study in 20 healthy subjects has shown that the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
Slovenian: Poleg tega je študija pri 20 zdravih osebah z različnimi merili, ki kažejo na način delovanja zdravila v telesu, pokazala, da enaki odmerki obeh zdravil, dani z injiciranjem pod kožo, povzročijo podobne učinke na faktorje strjevanja krvi.
English: It is not intended to provide practical advice on how to use Thorinane.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The reference medicine for Thorinane is Clexane.
Slovenian: Referenčno zdravilo za zdravilo Thorinane je zdravilo Clexane.
English: The active substance in Thorinane, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Slovenian: Zdravilna učinkovina v zdravilu Thorinane, enoksaparin, spada v skupino antikoagulacijskih zdravil, imenovanih „nizkomolekularni heparini“.
English: Extensive laboratory studies comparing Thorinane with Clexane have shown that Thorinane is highly similar to Clexane in terms of structure, purity and biological activity.
Slovenian: Obsežne laboratorijske študije, v katerih so zdravilo Thorinane primerjali z zdravilom Clexane, so pokazale, da je zdravilo Thorinane po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Clexane.
English: For the full list of all side effects reported with Thorinane, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Thorinane, glejte navodilo za uporabo.
English: Thorinane is available as a solution for injection in pre-filled syringes.
Slovenian: Zdravilo Thorinane je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
English: Thorinane is a ‘biosimilar medicine'.
Slovenian: Zdravilo Thorinane je „podobno biološko zdravilo“.
English: How does Thorinane work?
Slovenian: Kako zdravilo Thorinane deluje?
English: How is Thorinane used?
Slovenian: Kako se zdravilo Thorinane uporablja?
English: The active substance in Thorinane is enoxaparin sodium.
Slovenian: Zdravilna učinkovina v zdravilu Thorinane je natrijev enoksaparinat.
English: Number of Days per Week
Slovenian: Število dni na teden
English: (See section 4.4).
Slovenian: (Glejte poglavje 4.4.)
English: • you are over 70 years old.
Slovenian: • če ste starejši od 70 let.
English: The majority of the dose was excreted within 96 hours.
Slovenian: Večina odmerka se je izločila v 96 urah.
English: This condition requires immediate medical attention.
Slovenian: To stanje zahteva takojšnjo zdravniško pomoč.
English: • Alcohol abuse.
Slovenian: • zloraba alkohola.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 July 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 3. julij 2008
English: They may raise your risk of having heart problems.
Slovenian: Ti lahko povečajo vaše tveganje za težave s srcem.
English: It contains two different active substances:
Slovenian: Vsebuje dve različni zdravilni učinkovini:
English: • you have any allergies.
Slovenian: • če imate kakšne alergije.
English: • You are pregnant or plan to become pregnant.
Slovenian: • če ste noseči ali nameravate zanositi.
English: In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Slovenian: V primeru prevelikega odmerjanja je smiselno uporabiti običajne simptomatske in podporne ukrepe.
English: • you drink large amounts of alcohol.
Slovenian: • če pijete veliko alkohola.
English: What should I know about cholesterol and triglycerides?
Slovenian: Kaj morate vedeti o holesterolu in trigliceridih?
English: • You should start by taking one tablet a day.
Slovenian: • Na začetku morate jemati po eno tableto na dan.
English: • you have high blood sugar or diabetes.
Slovenian: • če imate visok krvni sladkor ali sladkorno bolezen.
English: Blood tests and monitoring
Slovenian: Preiskave krvi in spremljanje
English: Daily doses greater than 2,000 mg/40 mg have not been studied and therefore are not recommended.
Slovenian: Dnevni odmerki, večji od 2.000 mg/40 mg, niso raziskani in zato niso priporočljivi.
English: • you have low levels of phosphorus.
Slovenian: • če imate nizko raven fosforja.
English: • In the event of an overdose, the following side effects were reported:
Slovenian: • V primeru prevelikega odmerjanja so poročali o naslednjih neželenih učinkih:
English: • If you miss a dose, do not take an extra dose.
Slovenian: • Če ste pozabili vzeti odmerek, ne vzemite dodatnega.
English: Do not store above 30°C.
Slovenian: Ne shranjujte pri temperaturi nad 30 °C.
English: Continue with your usual dose the next evening or at bedtime.
Slovenian: Nadaljujte z običajnim odmerkom naslednji dan zvečer ali pred spanjem.
English: • loss of control over urine and stool
Slovenian: • izguba nadzora nad zadrževanjem urina in blata
English: Pelzont with food, drink and alcohol
Slovenian: Zdravilo Pelzont skupaj s hrano, pijačo in alkoholom
English: • It is important to follow the advice given in section 3 How to take Pelzont.
Slovenian: • Pomembno je, da upoštevate navodila v poglavju 3 Kako jemati zdravilo Pelzont.
English: Tell your doctor about all of your medical conditions.
Slovenian: Zdravniku morate povedati za vse svoje zdravstvene težave.
English: Efficacy and safety of Pelzont in combination with simvastatin > 40 mg were not included in this study.
Slovenian: Učinkovitosti in varnosti zdravila Pelzont v kombinaciji s simvastatinom > 40 mg v tej študiji niso preučevali.
English: Your doctor will decide if Pelzont is right for you.
Slovenian: Zdravnik bo odločil, ali je zdravilo Pelzont primerno za vas.
English: • you are going to have an operation.
Slovenian: • če imate predvideno operacijo.
English: This clogging can slow or block blood flow to vital organs such as the heart and brain.
Slovenian: Zožitve lahko upočasnijo ali prekinejo dotok krvi v življenjsko pomembne organe, kot so srce in možgani.
English: Laropiprant is a potent and selective antagonist of DP1.
Slovenian: Laropiprant je močan in selektiven antagonist DP1.
English: In general, the between-group treatment effects on all lipid parameters were consistent across all patient subgroups examined.
Slovenian: Na splošno so se učinki zdravljenja na vse parametre lipidov med skupinami skladali v vseh analiziranih podskupinah bolnikov.
English: • when you cannot tolerate a statin or when a statin is not recommended for you.
Slovenian: • če statinov ne prenesete ali za vas niso priporočljivi.
English: Liver function tests are recommended before initiation, every 6 to 12 weeks for the first year, and periodically (e.g. semi-annually) thereafter.
Slovenian: Teste delovanja jeter je priporočljivo opraviti pred začetkom zdravljenja, nato na 6 do 12 tednov prvo leto, pozneje pa občasno (npr. na pol leta).
English: Rare: rhinitis
Slovenian: Redki: rinitis
English: The rate and extent of absorption are not altered with a high-fat meal.
Slovenian: Hitrost in obseg absorpcije se z zelo mastnim obrokom ne spremenita.
English: • midazolam, a medicine to make you sleepy before some medical procedures.
Slovenian: • midazolam, ki je zdravilo za uspavanje pred nekaterimi zdravstvenimi posegi.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
English: Adjustment of diet and/or hypoglycaemic therapy may be necessary.
Slovenian: Lahko je potrebna prilagoditev prehrane in/ali antidiabetičnega zdravljenja.
English: • decreased glucose (sugar) tolerance
Slovenian: • zmanjšana toleranca za glukozo (sladkor)
English: • Significant or unexplained hepatic dysfunction.
Slovenian: • Pomembna ali nepojasnjena motnja delovanja jeter.
English: • Personal or familial history of hereditary muscular disorders
Slovenian: • osebna ali družinska anamneza dednih boleznih mišic,
English: • sweating
Slovenian: • znojenje
English: • you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na nikotinsko kislino, laropiprant ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Weeks on Treatment
Slovenian: tedni zdravljenja
English: If flushing occurs, symptoms are generally most noticeable at first and usually lessen over time.
Slovenian: Če se pojavi zardevanje, so simptomi ponavadi najbolj izraziti na začetku jemanja in se sčasoma praviloma zmanjšajo.
English: This includes medicines obtained without a prescription, vitamins, and herbal supplements.
Slovenian: To velja tudi za zdravila, ki ste jih dobili brez recepta, za vitamine in zeliščne dodatke.
English: It is not known if Pelzont will harm your unborn baby.
Slovenian: Ni znano, ali zdravilo Pelzont škoduje nerojenemu otroku.
English: • you have heart problems.
Slovenian: • če imate težave s srcem.
English: Side effects of Pelzont are:
Slovenian: Neželeni učinki zdravila Pelzont so:
English: • Take Pelzont once a day, in the evening or at bedtime.
Slovenian: • Zdravilo Pelzont vzemite enkrat na dan, zvečer ali pred spanjem.
English: This means one or more active substances are released slowly over a period of time.
Slovenian: To pomeni, da se ena ali več zdravilnih učinkovin iz tablet počasi sprošča daljši čas.
English: Elderly patients No dose adjustment is required for elderly patients.
Slovenian: Starejši bolniki Pri starejših bolnikih odmerjanja ni treba prilagoditi.
English: • vitamins or supplements that contain nicotinic acid.
Slovenian: • vitamine ali dodatke, ki vsebujejo nikotinsko kislino.
English: • zidovudine, a medicine used for HIV.
Slovenian: • zidovudin, ki je zdravilo za HIV.
English: Laropiprant is highly bound (> 99 %) to plasma proteins, and its binding is independent of concentration.
Slovenian: Laropiprant je v veliki meri (> 99 %) vezan na beljakovine v plazmi in vezava ni odvisna od koncentracije.
English: • Age > 70 years
Slovenian: • starost nad 70 let,
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 30 °C.
English: INFORMATION IN BRAILLE Pelzont
Slovenian: PODATKI V BRAILLOVI PISAVI Pelzont
English: Also tell your doctor if you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese.
Slovenian: Zdravniku povejte tudi, če jemljete simvastatin (statin) ali zdravilo, ki vsebuje simvastatin, in ste Kitajec.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Pelzont to the woman.
Slovenian: Odločiti se je treba med nadaljevanjem/prenehanjem dojenja in nadaljevanjem/prenehanjem zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Pelzont za mater.
English: • increased blood pressure
Slovenian: • zvišan krvni tlak
English: If you have these symptoms talk to your doctor immediately.
Slovenian: Če imate katerega od teh simptomov, se takoj posvetujte z zdravnikom.
English: Though total mortality was similar in the two groups at five years, in a fifteen-year cumulative follow-up there were 11 % fewer deaths in the nicotinic acid group compared to the placebo cohort.
Slovenian: Po petih letih je bila sicer celotna umrljivost v obeh skupinah podobna, a med petnajstletnim kumulativnim spremljanjem so v skupini, ki je dobivala nikotinsko kislino, ugotovili 11 % manj smrti kot v kohorti s placebom.
English: Northumberland NE23 3JU United Kingdom
Slovenian: Northumberland NE23 3JU Velika Britanija
English: If these levels are found, in the absence of strenuous exercise, to be significantly elevated (> 5 x ULN), treatment should be stopped.
Slovenian: Če je pri bolniku, ki redno ne trenira, ta raven pomembno zvišana (> 5 x ZMN), je treba zdravljenje prekiniti.
English: • skin disorder with dark velvety plaques called acanthosis nigricans
Slovenian: • bolezen kože s temnimi, žametastimi lehami, ki se imenuje acanthosis nigricans
English: • After 4 weeks, your doctor may raise your dose to two tablets a day.
Slovenian: • Po 4 tednih vam zdravnik lahko odmerek poveča na dve tableti na dan.
English: • Arterial bleeding.
Slovenian: • Arterijska krvavitev.
English: Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Slovenian: Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU Velika Britanija
English: Pelzont is used in addition to diet
Slovenian: Zdravilo Pelzont se uporablja poleg diete za:
English: Animal studies have shown excretion of laropiprant in milk.
Slovenian: Študije na živalih so pokazale, da se laropiprant izloča v mleko.
English: Safety and effectiveness of Pelzont in paediatric patients under the age of 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Pelzont pri pediatričnih bolnikih, mlajših od 18 let, nista bili dokazani.
English: Laropiprant also has affinity for the thromboxane A2 receptor (TP) (although it is substantially less potent at TP as compared to DP1).
Slovenian: Laropiprant ima tudi afiniteto za receptor (TP) za tromboksan A2 (čeprav je za TP veliko manj močna kot za DP1).
English: Treatment with nicotinic acid reduces the risk of death and cardiovascular events, and slows progression or promotes regression of atherosclerotic lesions.
Slovenian: Zdravljenje z nikotinsko kislino zmanjšuje tveganje za smrt in srčno-žilne dogodke ter upočasni napredovanje ali pripomore k nazadovanju aterosklerotičnih sprememb.
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Therefore, Pelzont should not be used during pregnancy unless clearly necessary.
Slovenian: Zato se zdravila Pelzont ne sme uporabljati pri nosečnicah, razen če to ni nujno.
English: If you take aspirin for any other reason, continue to follow your doctor's advice.
Slovenian: Če jemljete acetilsalicilno kislino zaradi drugih vzrokov, še naprej upoštevajte navodila zdravnika.
English: Therefore, Pelzont should not be used in children and adolescents under 18 years of age.
Slovenian: Zato se zdravila Pelzont ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: What Pelzont is and what it is used for What you need to know before you take Pelzont How to take Pelzont
Slovenian: Kaj je zdravilo Pelzont in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pelzont Kako jemati zdravilo Pelzont
English: Figure 2 Percentage of Patients with Moderate or Greater Flushing Symptoms Across Weeks 1-32
Slovenian: Slika 2 Odstotek bolnikov z zmernimi ali izrazitejšimi simptomi zardevanja od 1. do 32. tedna
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/460/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/460/012
English: The safety of concomitant administration of nicotinic acid and laropiprant was assessed in dogs and rats.
Slovenian: Varnost sočasne uporabe nikotinske kisline in laropipranta so ocenili pri psih in podganah.
English: • when you cannot control your cholesterol levels with a statin alone (class of cholesterol-lowering medicines working in the liver);
Slovenian: • če holesterola ne morete obvladati samo s statinom (statini so skupina zdravil za zniževanje holesterola, ki delujejo v jetrih).
English: Effect on skeletal muscle
Slovenian: Vpliv na skeletne mišice
English: • rapid or irregular heartbeat
Slovenian: • hitro ali nepravilno bitje srca
English: ▲ Pelzont  nicotinic acid (laropiprant withdrawn at Week 21)
Slovenian: ▲ Pelzont  nikotinska kislina (ukinitev laropipranta v 21. tednu)
English: Hypophosphatemia
Slovenian: Hipofosfatemija
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: In most people, at first there are no signs of cholesterol problems.
Slovenian: Pri večini ljudi nenormalna raven holesterola sprva ne povzroča nobenih bolezenskih znakov.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to human use.
Slovenian: V predkliničnih študijah so učinke opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za uporabo pri ljudeh.
English: • you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese.
Slovenian: • če jemljete simvastatin (statin) ali zdravilo, ki vsebuje simvastatin, in ste Kitajec.
English: Uncommon: palpitations Rare: atrial fibrillation and other cardiac arrhythmias; tachycardia
Slovenian: Redki: atrijska fibrilacija in druge srčne aritmije; tahikardija
English: Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Pelzont with or without a statin (see section 4.4).
Slovenian: Klinično pomembno zvišanje CK (≥ 10 x ZNM) so opazili pri 0,3 % bolnikov, ki so dobivali zdravilo Pelzont s statinom ali brez njega (glejte poglavje 4.4).
English: Therefore, laropiprant is not an inducer or inhibitor of CYP3A4.
Slovenian: Laropiprant torej ne inducira in ne zavira CYP3A4.
English: Average number of days per week with moderate or greater* flushing symptoms across weeks 1-24
Slovenian: Povprečno število dni na teden z zmernimi ali izrazitejšimi* simptomi zardevanja od 1. do 24. tedna
English: In urine, the primary component is the acyl glucuronide conjugate (64 % of radioactivity) with smaller contributions from the parent compound (5 %).
Slovenian: V urinu je glavna z zdravilom povezana snov acilglukuronidni konjugat (64 % radioaktivnosti), z manjšim prispevkom matične spojine (5 %).
English: The major component (73 % of radioactivity) in faeces is laropiprant (comprising unabsorbed active substance and/or hydrolysed glucuronic acid conjugate).
Slovenian: Glavna snov (73 % radioaktivnosti) v blatu je laropiprant (obsega neabsorbirano zdravilo in/ali hidrolizirani konjugat z glukuronsko kislino).
English: During controlled clinical trials in healthy subjects, single doses of up to 900 mg laropiprant and multiple doses up to 450 mg once daily for 10 days were generally well tolerated.
Slovenian: V kontroliranih kliničnih preskušanjih so zdravi preiskovanci večinoma dobro prenašali posamične odmerke do 900 mg laropipranta in večkratne odmerke do 450 mg enkrat na dan 10 dni.
English: Midazolam: Multiple doses of laropiprant 40 mg did not affect the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate.
Slovenian: Midazolam: Večkratni odmerki 40 mg laropipranta niso vplivali na farmakokinetiko midazolama, ki je občutljiv substrat CYP3A4.
English: In diabetic patients a median increase in HbA1c of 0.2 % was observed (where modification of hypoglycaemic therapy was allowed).
Slovenian: Pri sladkornih bolnikih so opazili povečanje HbA1c (mediana vrednost) za 0,2 % (pri čemer je bila dovoljenja prilagoditev antidiabetičnega zdravljenja).