FrancophonIA/ELRC3.0 huggingface dataset:
English: Two main studies of Elocta showed that the medicine is effective at both preventing and treating bleeding episodes.
Slovenian: Glavni študiji z zdravilom Elocta sta pokazali, da je učinkovito pri preprečevanju in zdravljenju krvavitev.
English: Elocta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Slovenian: Predpisovanje in izdaja zdravila Elocta je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika z izkušnjami z zdravljenjem hemofilije.
English: Elocta is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Slovenian: Zdravilo Elocta se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (dedno motnjo strjevanja krvi zaradi pomanjkanja faktorja VIII).
English: For the full list of side effects and restrictions of Elocta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Elocta glejte navodilo za uporabo.
English: How does Elocta work?
Slovenian: Kako zdravilo Elocta deluje?
English: How is Elocta used?
Slovenian: Kako se zdravilo Elocta uporablja?
English: The Member States shall ensure that the Marketing Authorisation Holder complies with the following requirements in their Member State:
Slovenian: Države članice bodo poskrbele, da imetnik dovoljenja za promet v njihovi državi članici izpolni naslednje zahteve:
English: The MULTAQ Information Card should contain the following key safety messages:
Slovenian: Informativna kartica o zdravilu MULTAQ mora vsebovati naslednja ključna sporočila o varnosti:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZPOLNITI DRŽAVE ČLANICE
English: If ALT levels are confirmed to be ≥3 × ULN after re-measurement, treatment with dronedarone should be withdrawn.
Slovenian: Če je izvid ALT po ponovni meritvi potrjeno ≥ 3-kratna ZNM, je treba prenehati zdravljenje z dronedaronom.
English: • That the use of MULTAQ is not recommended in patients with recent (1-3 months) stable NYHA class III heart failure or with LVEF <35%.
Slovenian: • Zdravila MULTAQ ni priporočljivo uporabljati pri bolnikih z nedavnim (od 1 do 3 mesece) stabilnim srčnim popuščanjem v III. razredu po NYHA ali z LVEF < 35 %.
English: The content and format of the MULTAQ Information Card, together with the communication and distribution plan should be agreed with the National Competent Authority in each Member State prior to distribution.
Slovenian: O vsebini in obliki informativne kartice o zdravilu MULTAQ ter o načrtu komunikacije in distribucije le-te, se je potrebno predhodno uskladiti z pristojnimi nacionalnimi organi v vsaki državi članici.
English: • That patients should be counselled that: they should consult a physician if they develop or experience worsening signs or symptoms of heart failure; they should immediately report to a physician any symptoms of potential liver injury; MULTAQ interacts with a number of medicines; if they consult other doctors they should inform them that they are taking MULTAQ; they should not take St John's Wort with MULTAQ; they should avoid grapefruit juice.
Slovenian: • Bolnikom je treba povedati, da: se morajo posvetovati z zdravnikom, če so opazili pojav ali so doživeli poslabšanje znakov ali simptomov srčnega popuščanja; morajo nemudoma poročati zdravniku o kakršnihkoli znakih možne poškodbe jeter; zdravilo MULTAQ medsebojno deluje s številnimi zdravili; v primeru posveta pri drugih zdravnikih le-tem povedo, da jemljejo zdravilo MULTAQ; skupaj z zdravilom MULTAQ ne smejo uporabljati šentjanževke; se morajo izogibati grenivkinemu soku.
English: The MULTAQ Information Card should contain a list of drugs which interact with MULTAQ classified according to the seriousness of the interaction (eg contraindication, not recommended, use with caution).
Slovenian: Informativna kartica o zdravilu MULTAQ mora obsegati seznam zdravil, ki medsebojno delujejo z zdravilom MULTAQ, razvrščenih glede na resnost medsebojnega delovanja (npr. kontraindicirana, nepriporočljiva, uporabljajte previdno).
English: • That plasma creatinine levels may rise initially due to inhibition of the renal tubular excretion of creatinine and are not necessarily indicative of a deterioration in renal function.
Slovenian: • Uvodoma se lahko zaradi zavrtja ledvičnega tubularnega izločanja kreatinina koncentracija kreatinina v plazmi poveča, vendar to ne pomeni nujno poslabšanja delovanja ledvic.
English: • That MULTAQ must not be used in patients with unstable haemodynamic conditions including patients with symptoms of heart failure at rest or with minimal exertion (corresponding to NYHA class IV and unstable class III patients).
Slovenian: • Zdravila MULTAQ se ne sme uporabljati pri bolnikih z nestabilnimi hemodinamskimi stanji, vključno z bolniki, ki imajo simptome srčnega popuščanja v mirovanju ali med minimalnim naporom (to ustreza bolnikom v IV. razredu po NYHA in nestabilnim bolnikom v III. razredu po NYHA).
English: o Class I or Class III antiarrhythmics.
Slovenian: o antiaritmiki iz I. in III. skupine.
English: • As the MULTAQ Information Card does not include all warnings or contraindications, the SPC should be referred to prior to prescribing MULTAQ and also prior to prescribing additional drugs to a patient already taking MULTAQ.
Slovenian: • Informativna kartica o zdravilu MULTAQ ne vsebuje vseh opozoril ali kontraindikacij, zato je treba pred predpisovanjem zdravila MULTAQ prebrati njegov povzetek glavnih značilnosti; enako velja pred predpisovanjem dodatnih zdravil bolnikom, ki že jemljejo zdravilo MULTAQ.
English: The Marketing Authorisation Holder shall ensure that Health care professionals who intend to prescribe or dispense MULTAQ are provided with an SPCand the MULTAQ Information Card.
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravstveni delavci, ki nameravajo predpisovati ali izdajati zdravilo MULTAQ dobili povzetek glavnih značilnosti zdravila (SmPC) in informativno kartico o zdravilu MULTAQ.
English: • Use with caution: in association with digoxin, beta blockers, calcium antagonists, statins and vitamin K antagonists.
Slovenian: • Uporabljajte previdno: skupaj z digoksinom, zaviralci beta, kalcijevimi antagonisti, statini in antagonisti vitamina K.
English: o potential torsades de pointes inducers including phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides.
Slovenian: o zdravila, ki lahko izzovejo torsade de pointes, vključno s fenotiazini, cisapridom, bepridilom, tricikličnimi antidepresivi, terfenadinom in nekaterimi peroralnimi makrolidi.
English: • Not recommended/to be avoided: o grapefruit juice, o potent CYP3A4 inducers including rifampicin, phenobarbital, carbamazepine, phenytoin, St John's Wort o dabigatran.
Slovenian: • Nepriporočljiva/treba se jim je izogibati: o grenivkin sok, o močni induktorji CYP3A4, vključno z rifampicinom, fenobarbitalom, karbamazepinom, fenitoinom, šentjanževko, o dabigatran.
English: • That liver function tests should be performed prior and during treatment.
Slovenian: • Pred zdravljenjem in med njim je potrebno opravljati teste jetrne funkcije.
English: • Contraindication: o CYP3A inhibitors including ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir.
Slovenian: • Kontraindicirana: o zaviralci CYP3A vključno s ketokonazolom, itrakonazolom, vorikonazolom, pozakonazolom, telitromicinom, klaritromicinom, nefazodonom in ritonavirjem.
English: This summary was last updated in 08-2015.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2015.
English: Its use during the first three months of pregnancy is not recommended.
Slovenian: Uporaba zdravila v prvem tromesečju nosečnosti ni priporočljiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalmono on 16 December 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kinzalmono, veljavno po vsej Evropski uniji, izdala 16. decembra 1998.
English: The full EPAR for Kinzalmono can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kinzalmono je na voljo na spletni strani agencije: : ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Kinzalmono?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kinzalmono?
English: This is a summary of the European public assessment report (EPAR) for Kinzalmono.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kinzalmono.
English: Kinzalmono must not be used in women who are more than three months pregnant.
Slovenian: Zdravila Kinzalmono ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
English: A risk management plan has been developed to ensure that Kinzalmono is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Kinzalmono je bil pripravljen načrt obvladovanja tveganj.
English: The combination of the two medicines was no more effective than either medicine taken alone and was linked to an increased risk of side effects.
Slovenian: Kombinacija obeh zdravil ni bila učinkovitejša od jemanja teh zdravil kot samostojnih zdravil in je bila povezana z večjim tveganjem za pojav neželenih učinkov.
English: If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Slovenian: Če želena vrednost krvnega tlaka ni dosežena, se lahko odmerek poveča na 80 mg ali pa doda drugo zdravilo za zdravljenje hipertenzije, kot je hidroklorotiazid.
English: Other information about Kinzalmono
Slovenian: Druge informacije o zdravilu Kinzalmono
English: Kinzalmono is used to treat essential hypertension (high blood pressure) in adults.
Slovenian: Zdravilo Kinzalmono se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kinzalmono.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Kinzalmono is a medicine that contains the active substance telmisartan.
Slovenian: Kinzalmono je zdravilo, ki vsebuje zdravilno učinkovino telmisartan.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Slovenian: Uporablja se pri bolnikih, ki so imeli v preteklosti težave zaradi krvnih strdkov (kot so srčno obolenje, možganska kap ali bolezen arterij) ali pri katerih je sladkorna bolezen tipa 2 poškodovala enega od organov (kot so oči, srce ali ledvice).
English: What benefit has Kinzalmono shown during the studies?
Slovenian: Kakšne koristi je zdravilo Kinzalmono izkazalo med študijami?
English: The CHMP decided that Kinzalmono's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Kinzalmono večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: For more information about treatment with Kinzalmono, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kinzalmono preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The active substance in Kinzalmono, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Kinzalmono, telmisartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Slovenian: To povzroči padec krvnega tlaka in zmanjšanje tveganja, ki je povezano z visokim krvnim tlakom, kot sta srčni infarkt ali možganska kap.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kinzalmono, 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 in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For the prevention of cardiovascular problems, 80 mg Kinzalmono once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Slovenian: Za preprečevanje srčno-žilnih težav so zdravilo Kinzalmono v odmerku 80 mg enkrat dnevno proučevali v eni glavni študiji, v katero je bilo vključenih skoraj 26 000 bolnikov, starih 55 let ali več, ki so imeli srčno ali arterijsko bolezen, so doživeli možgansko kap ali imeli sladkorno bolezen in pri katerih je obstajalo veliko tveganje za srčno-žilne težave.
English: Hypotension may be more common in patients receiving Kinzalmono to prevent cardiovascular problems.
Slovenian: Hipotenzija je lahko pogostejša pri bolnikih, ki zdravilo Kinzalmono jemljejo za preprečevanje srčno-žilnih težav.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalmono must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 ali bolnikih z zmerno ali hudo okvaro ledvic se zdravilo Kinzalmono ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (zdravilo za zdravljenje esencialne hipertenzije).
English: In the treatment of essential hypertension, Kinzalmono was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Slovenian: Kar zadeva zdravljenje esencialne hipertenzije, je bilo zdravilo Kinzalmono pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje hipertenzije.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Slovenian: Hkrati srcu olajša črpanje krvi, kar pripomore k manjšemu tveganju za pojav srčno-žilnih težav v prihodnosti.
English: What is the risk associated with Kinzalmono?
Slovenian: Kakšna tveganja so povezana z zdravilom Kinzalmono?
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Slovenian: Telmisartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, prepreči učinek hormona, kar privede do razširitve krvnih žil.
English: Various doses of Kinzalmono were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Slovenian: Različne odmerke zdravila Kinzalmono so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili za zniževanje krvnega tlaka (atenololom, lizinoprilom, enalaprilom in amlodipinom).
English: The doctor should monitor the patient's blood pressure closely when starting Kinzalmono, and may decide to adjust the patient's blood pressure-lowering medication.
Slovenian: Ob začetku zdravljenja z zdravilom Kinzalmono mora zdravnik skrbno spremljati bolnikov krvni tlak in se lahko odloči za prilagoditev odmerka zdravila za zniževanje bolnikovega krvnega tlaka.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Slovenian: (zelo počasen srčni utrip), hipotenzijo (nizek krvni tlak), dispnejo (oteženo dihanje), kašelj, bolečine v trebuhu (bolečine v želodcu), drisko, dispepsijo (zgago), napenjanje (vetrove), bruhanje, hiperhidrozo (prekomerno potenje), pruritus (srbenje), izpuščaje, mialgijo (bolečine v mišicah), bolečine v hrbtu, krče v mišicah, okvaro ledvic (zmanjšano delovanje ledvic), vključno z njihovo odpovedjo, bolečine v prsih, astenijo (šibkost) in povečane ravni kreatinina v krvi (znak razgradnje mišic).
English: Kinzalmono was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Slovenian: Zdravilo Kinzalmono so primerjali z ramiprilom (drugim zdravilom za preprečevanje srčno-žilnih težav) in kombinacijo obeh zdravil.
English: Side effects with Kinzalmono are not common.
Slovenian: Neželeni učinki zdravila Kinzalmono niso pogosti.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Slovenian: Bolniki z blago ali zmerno okvaro delovanja jeter ne smejo jemati odmerkov, ki presegajo 40 mg na dan.
English: For the treatment of essential hypertension, Kinzalmono has been studied in 2,647 patients who took Kinzalmono either alone or in combination with hydrochlorothiazide.
Slovenian: Za zdravljenje esencialne hipertenzije so zdravilo Kinzalmono raziskali pri 2 647 bolnikih, ki so zdravilo Kinzalmono jemali bodisi kot samostojno zdravilo bodisi v kombinaciji s hidroklorotiazidom.
English: Kinzalmono is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Slovenian: Zdravilo Kinzalmono se uporablja tudi za preprečevanje kardiovaskularnih težav (težav s srcem in krvnimi žilami), kot sta srčni infarkt ali možganska kap.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Slovenian: Priporočeni odmerek za preprečevanje srčno-žilnih težav je 80 mg enkrat na dan.
English: For the treatment of essential hypertension, the usual recommended dose of Kinzalmono is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Slovenian: Običajni priporočeni odmerek zdravila Kinzalmono za zdravljenje esencialne hipertenzije znaša 40 mg enkrat dnevno, čeprav za nekatere bolnike zadostuje že 20-miligramski odmerek enkrat na dan.
English: For the full list of all side effects reported with Kinzalmono, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kinzalmono, glejte navodilo za uporabo.
English: Why has Kinzalmono been approved?
Slovenian: Zakaj je bilo zdravilo Kinzalmono odobreno?
English: Kinzalmono must not be used in people who have severe liver problems or bile problems.
Slovenian: Zdravila Kinzalmono prav tako ne smejo uporabljati osebe, ki imajo huda obolenja jeter ali žolčnika.
English: In the prevention of cardiovascular problems, Kinzalmono had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Slovenian: Pri preprečevanju srčno-žilnih težav je bilo zdravilo Kinzalmono enako učinkovito kot ramipril, pri čemer je okoli 17 % bolnikov umrlo, bilo hospitaliziranih zaradi srčno-žilnih težav oziroma je doživelo srčni napad ali možgansko kap.
English: What is Kinzalmono used for?
Slovenian: Za kaj se zdravilo Kinzalmono uporablja?
English: How does Kinzalmono work?
Slovenian: Kako zdravilo Kinzalmono deluje?
English: How is Kinzalmono used?
Slovenian: Kako se zdravilo Kinzalmono uporablja?
English: What is Kinzalmono?
Slovenian: Kaj je zdravilo Kinzalmono?
English: How has Kinzalmono been studied?
Slovenian: Kako je bilo zdravilo Kinzalmono raziskano?
English: The marketing authorisation was renewed on 17 August 2003 and on 17 August 2008.
Slovenian: Dovoljenje za promet z zdravilom je bilo obnovljeno 17. avgusta 2003 in 17. avgusta 2008.
English: NovoNorm is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Slovenian: Zdravilo NovoNorm ni priporočljivo za bolnike, mlajše od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti zdravila v tej starostni skupini.
English: It is available as round tablets (white: 0.5 mg; yellow: 1 mg; peach: 2 mg).
Slovenian: Na voljo je v obliki okroglih tablet (bele: 0,5 mg; rumene: 1 mg; barve breskve: 2 mg).
English: NovoNorm is taken before meals, normally up to 15 minutes before each main meal.
Slovenian: Zdravilo NovoNorm se jemlje pred obroki, običajno do 15 minut pred vsakim glavnim obrokom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoNorm to Novo Nordisk A/S on 17 August 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom NovoNorm, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/S dne 17. avgusta 1998.
English: Other information about NovoNorm:
Slovenian: Druge informacije o zdravilu NovoNorm:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOVONORM EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NOVONORM Povzetek EPAR za javnost
English: Another study looked at the effect of adding NovoNorm to metformin.
Slovenian: Druga študija je preučevala učinek dodajanja zdravila NovoNorm k metforminu.
English: The Committee recommended that NovoNorm be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo NovoNorm odobri dovoljenje za promet.
English: NovoNorm is a medicine that contains the active substance repaglinide.
Slovenian: NovoNorm je zdravilo, ki vsebuje zdravilno učinkovino repaglinid.
English: What benefit has NovoNorm shown during the studies?
Slovenian: Kakšne koristi je zdravilo NovoNorm izkazalo med študijami?
English: NovoNorm has been studied in 45 ‘clinical pharmacology' studies (looking at how the medicine works in the body) and 16 clinical trials (looking at its effects in treating type 2 diabetes patients).
Slovenian: Zdravilo NovoNorm so preučevali v 45 kliničnih farmakoloških študijah (v katerih so preučevali, kako zdravilo deluje v telesu) in 16 kliničnih preskušanjih (v katerih so preučevali njegove učinke pri zdravljenju bolnikov s sladkorno boleznijo tipa 2).
English: NovoNorm should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients.
Slovenian: Zdravila NovoNorm ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) repaglinid ali katero koli drugo sestavino zdravila.