FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of lack of experience, Saxenda should not be used during breast-feeding.
Slovenian: Zaradi pomanjkanja izkušenj se zdravila Saxenda med dojenjem ne sme uporabljati.
English: 5 After your injection • Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.
Slovenian: 5 Po injiciranju • Konico igle vstavite v zunanji pokrovček igle na ravni površini, ne da bi se dotaknili igle ali zunanjega pokrovčka igle.
English: Clear and colourless or almost colourless, isotonic solution; pH=8.15.
Slovenian: Bistra in brezbarvna ali skoraj brezbarvna, izotonična raztopina s pH 8,15.
English: Patients were randomly allocated to either liraglutide on a daily dose of up to 1.8 mg (4,668) or placebo (4,672), both on a background of standard of care.
Slovenian: Bolniki so bili naključno razporejeni v skupino z dnevnim odmerkom liraglutida do 1,8 mg (4.668) ali placebom (4.672), ki so ju prejemali poleg standardne oskrbe.
English: Novo Nordisk A/S Novo Allé 2880 Bagsværd Denmark
Slovenian: Novo Nordisk A/S Novo Allé 2880 Bagsvaerd Danska
English: If there is still no drop, change the needle and repeat step 2 ‘Check the flow' once more.
Slovenian: Če se kapljica še vedno ne pojavi, zamenjajte iglo in še enkrat ponovite korak 2 "Preverite pretok".
English: More frequent blood testing to determine the ability of your blood to clot may be required.
Slovenian: Morda boste morali opraviti več preiskav krvi, da se oceni sposobnost strjevanja vaše krvi.
English: If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment.
Slovenian: Če bolnik dviga odmerka ne prenaša dva zaporedna tedna, razmislite o prekinitvi zdravljenja.
English: The predicted mean weight loss in early responders who complete 1 year of treatment is 11.2% of their baseline body weight (9.7% for males and 11.6% for females).
Slovenian: Napovedana povprečna izguba telesne mase pri bolnikih z zgodnjim odzivom, ki se zdravijo 1 leto, je 11,2 % začetne telesne mase (9,7 % za moške in 11,6 % za ženske).
English: • Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Slovenian: • Osebe, ki skrbijo za bolnika, morajo biti pri ravnanju z uporabljenimi iglami zelo pazljive, da se ne bi zbodle in navzkrižno okužile.
English: Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.
Slovenian: Zdravljenje z zdravilom Saxenda je treba prekiniti po 12 tednih uporabe odmerka 3,0 mg/dan, v kolikor bolniki niso izgubili vsaj 5 % začetne telesne mase.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki
English: When initiating Saxenda, it should be considered to reduce the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.
Slovenian: Ob uvedbi zdravila Saxenda se mora razmisliti o zmanjšanju odmerka sočasno uporabljanega insulina ali sekretagogov insulina (npr. sulfonilsečnine), da bi zmanjšali tveganje za hipoglikemijo.
English: • Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation - these usually go away after a few days or weeks.
Slovenian: • občutek slabosti (siljenje na bruhanje), bruhanje, driska, zaprtost - navadno minejo po nekaj dneh ali tednih
English: Clinical trials suggest that liraglutide improves and sustains beta-cell function, according to HOMA-B and the proinsulin-to-insulin ratio.
Slovenian: Klinična preskušanja kažejo, da liraglutid izboljša in vzdržuje delovanje celic beta, glede na oceno delovanja celic beta s homeostatskim modelom (HOMA-B) in razmerje med proinsulinom in insulinom.
English: If you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder.
Slovenian: Če izgubite veliko telesne mase, ste podvrženi tveganju za žolčne kamne in posledično za vnetje žolčnika.
English: Please see section ‘Description of selected adverse reactions' for further information.
Slovenian: Za več informacij glejte podpoglavje "Opis izbranih neželenih učinkov".
English: Events reported included severe nausea and severe vomiting which are also the expected symptoms of an overdose with liraglutide.
Slovenian: Ti dogodki so vključevali hudo navzeo in hudo bruhanje, ki sta pričakovana simptoma prevelikega odmerjanja z liraglutidom.
English: Based on the results of population pharmacokinetic analysis, females have 24% lower weight adjusted clearance of liraglutide compared to males.
Slovenian: Glede na rezultate populacijske farmakokinetične analize imajo ženske za 24 % nižji očistek liraglutida, korigiran glede na težo, kot moški.
English: If a drop still does not appear, dispose of the pen and use a new one.
Slovenian: Če se kapljica še vedno ne pojavi, zavrzite injekcijski peresnik in uporabite novega.
English: Tell your doctor if you have diabetes.
Slovenian: Obvestite zdravnika, če imate sladkorno bolezen.
English: The 0 must line up with the dose pointer.
Slovenian: Oznaka 0 mora biti poravnana s kazalnikom odmerka.
English: The starting dose is 0.6 mg once daily.
Slovenian: Začetni odmerek je 0,6 mg enkrat na dan.
English: Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination.
Slovenian: Izločanje Endogena presnova liraglutida je podobna presnovi velikih beljakovin in ni nobenega določenega organa, ki bi veljal kot glavna pot izločanja.
English: The efficacy and safety of liraglutide for weight management in conjunction with reduced calorie intake and increased physical activity were studied in four phase 3 randomised, double-blind, placebocontrolled trials which included a total of 5,358 patients.
Slovenian: Učinkovitost in varnost liraglutida za obvladovanje telesne mase v kombinaciji z zmanjšanim vnosom kalorij in povečano telesno dejavnostjo so preučevali v štirih randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih tretje faze, v katera je bilo vključenih 5.358 bolnikov.
English: Saxenda is unlikely to affect your ability to drive and use machines.
Slovenian: Malo verjetno je, da bi zdravilo Saxenda vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: The patient should be observed for clinical signs of dehydration and blood glucose should be monitored.
Slovenian: Bolnike je treba opazovati glede kliničnih znakov dehidracije, prav tako pa je treba spremljati koncentracijo glukoze v krvi.
English: For patients who experience a clinically relevant sustained increase in resting heart rate, treatment with liraglutide should be discontinued.
Slovenian: Bolnikom, pri katerih se pojavi klinično pomembno trajno zvišanje frekvence srčnega utripa v mirovanju, je treba zdravljenje z liraglutidom prekiniti.
English: Treatment with liraglutide significantly improved systolic blood pressure and waist circumference compared with placebo (tables 3, 4 and 5).
Slovenian: Zdravljenje z liraglutidom je pomembno izboljšalo sistolični krvni tlak in obseg pasu v primerjavi s placebom (preglednice 3, 4 in 5).
English: A clinically relevant interaction with active substances with poor solubility or narrow therapeutic index such as warfarin cannot be excluded.
Slovenian: Klinično pomembnega medsebojnega delovanja liraglutida in učinkovin s slabo topnostjo in ozkim terapevtskim indeksom, kot je na primer varfarin, ni mogoče izključiti.
English: • Do not mix Saxenda up with other medicines that you inject (e.g. insulins).
Slovenian: • Zdravila Saxenda ne smete zamešati z drugimi zdravili za injiciranje, ki jih uporabljate (npr. insulini).
English: You can select up to 3.0 mg per dose.
Slovenian: Izberete lahko največ 3,0 mg na odmerek.
English: Do not stop using Saxenda without talking to your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Saxenda, ne da bi se o tem prej posvetovali z zdravnikom.
English: For the proportions of patients losing ≥5/>10% body weight, estimated odds ratios are presented.
Slovenian: Pri deležih bolnikov, ki so izgubili ≥ 5/> 10 % telesne mase, je navedeno ocenjeno razmerje obetov.
English: Pharmacokinetic properties were assessed in clinical pharmacology studies in the paediatric population with obesity aged 12-17 years (14 patients, body weight 80-122 kg) and 7-11 years (16 patients, body weight 45-87 kg) respectively.
Slovenian: Pediatrična populacija Farmakokinetične lastnosti so ovrednotili v kliničnih farmakoloških študijah pri pediatričnih bolnikih z debelostjo, starih 12-17 let (14 bolnikov s telesno maso 80-122 kg) in 7-11 let (16 bolnikov s telesno maso 45-87 kg).
English: The fact that substantial weight loss can increase the risk of cholelithiasis and thereby cholecystitis only partially explained the higher rate with liraglutide.
Slovenian: Dejstvo, da lahko znatna izguba telesne mase poveča tveganje za holelitiazo in posledično holecistitis, le deloma obrazloži večjo pojavnost pri liraglutidu.
English: Patients should be informed of the symptoms of increased heart rate (palpitations or feelings of a racing heartbeat while at rest).
Slovenian: Bolnike je treba seznaniti s simptomi zvišane frekvence srčnega utripa (palpitacije ali občutek hitrega srčnega utripa v mirovanju).
English: What Saxenda is and what it is used for What you need to know before you use Saxenda How to use Saxenda
Slovenian: Kaj je zdravilo Saxenda in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Saxenda Kako uporabljati zdravilo Saxenda
English: Substances added to Saxenda may cause degradation of liraglutide.
Slovenian: Snovi, dodane zdravilu Saxenda, lahko povzročijo razgradnjo liraglutida.
English: Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.
Slovenian: Zdravnik vam bo morda prilagodil odmerek zdravila za sladkorno bolezen, da prepreči pojav nizkega krvnega sladkorja.
English: The vast majority of these had established cardiovascular disease.
Slovenian: Velika večina bolnikov je imela dokazano srčno-žilno bolezen.
English: Talk to your doctor if you have or have had a disease of the pancreas.
Slovenian: Posvetujte se z zdravnikom, če imate ali ste kdaj imeli bolezen trebušne slinavke.
English: • However, if more than 12 hours have passed since you should have used Saxenda, skip the missed dose and inject your next dose the following day at the usual time.
Slovenian: • Če pa je minilo že več kot 12 ur, odkar bi morali uporabiti zdravilo Saxenda, preskočite ta odmerek in injicirajte naslednji odmerek kot ponavadi naslednji dan.
English: Based on the exposure response data, no dose adjustment is necessary based on gender.
Slovenian: Glede na podatke o odzivu na zdravilo, prilagoditev odmerka glede na spol ni potrebna.
English: The mean clearance following subcutaneous administration of liraglutide is approximately 0.9-1.4 L/h with an elimination half-life of approximately 13 hours.
Slovenian: Povprečen očistek po subkutani aplikaciji odmerka liraglutida je približno 0,9-1,4 l/h, eliminacijski razpolovni čas pa je približno 13 ur.
English: Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis.
Slovenian: Bolnike je treba seznaniti z značilnimi simptomi holelitiaze in holecistitisa.
English: Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of
Slovenian: Zdravilo Saxenda se uporablja kot dodatno zdravljenje k dieti z zmanjšanim vnosom kalorij in povečani telesni dejavnosti za obvladovanje telesne mase pri odraslih bolnikih z začetnim indeksom telesne mase (ITM):
English: The liraglutide exposure in adolescents (age 12-17 years) was similar to that in adults with obesity.
Slovenian: Pri mladostnikih (starih 12-17 let) je bila izpostavljenost liraglutidu podobna kot pri odraslih z debelostjo.
English: Always watch the dose counter to know how many mg you inject.
Slovenian: Vedno glejte števec odmerka, da vidite, koliko mg injicirate.
English: Contents of the pack and other information What Saxenda contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Saxenda
English: The safety and efficacy of liraglutide for weight management have not been established in patients: - aged 75 years or more, - treated with other products for weight management, - with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain, - with severe renal impairment, - with severe hepatic impairment.
Slovenian: Varnost in učinkovitost liraglutida za obvladovanje telesne mase nista ugotovljeni pri bolnikih, ki: - so stari 75 let ali več, - uporabljajo druga zdravila za obvladovanje telesne mase, - imajo sekundarno debelost zaradi endokrinih ali prehranskih motenj ali zaradi zdravljenja z zdravili, ki lahko povzročijo porast telesne mase,
English: The primary endpoint was the time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Slovenian: Primarni opazovani dogodek je bil čas od randomizacije do prvega pojava katerega od pomembnih srčno-žilnih neželenih dogodkov (Major Adverse Cardiovascular Events (MACE)): smrt zaradi srčno-žilnih zapletov, miokardni infarkt brez smrtnega izida ali možganska kap brez smrtnega izida.
English: If you feel dizziness be extra careful while driving or using machines.
Slovenian: Če se vam pojavi omotica, morate biti pri upravljanju vozil in strojev še posebno previdni.
English: This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
Slovenian: Uporaba zdravila ni priporočljiva, če imate hude težave z želodcem ali črevesjem in se vam zato želodec počasneje prazni (gastropareza) ali če imate kronično vnetno črevesno bolezen.
English: Liraglutide lowers body weight in humans mainly through loss of fat mass with relative reductions in visceral fat being greater than for subcutaneous fat loss.
Slovenian: Liraglutid zmanjšuje telesno maso pri ljudeh v glavnem z zmanjševanjem mase maščobe, pri čemer je delež izgube visceralne maščobe večji od deleža izgube podkožne maščobe.
English: Saxenda was evaluated for safety in 5 double-blind, placebo controlled trials that enrolled 5,813 obese patients or overweight patients with at least one weight-related comorbidity.
Slovenian: Varnost zdravila Saxenda so ocenili v 5 dvojno slepih, s placebom nadzorovanih preskušanjih, v katera je bilo vključenih 5.813 bolnikov z debelostjo ali bolnikov s prekomerno telesno maso, ki so imeli vsaj eno z debelostjo povezano bolezen.
English: Saxenda is for subcutaneous use only.
Slovenian: Zdravilo Saxenda je namenjeno zgolj subkutani uporabi.
English: Change in Body Weight (%)
Slovenian: Sprememba telesne mase (%)
English: Cardiometabolic risk factors
Slovenian: Srčno-presnovni dejavniki tveganja
English: • increase of pancreatic enzymes, such as lipase and amylase.
Slovenian: • zvišanje koncentracije encimov trebušne slinavke (npr. lipaze in amilaze)
English: • you are taking warfarin or other medicines by mouth that reduce your blood clotting (anticoagulants).
Slovenian: • jemljete varfarin ali druga peroralna zdravila proti strjevanju krvi (antikoagulanti).
English: The dose selector changes the dose.
Slovenian: Z izbirnikom odmerka spreminjate odmerek.
English: Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyacetal, polycarbonate and acrylonitrile butadiene styrene.
Slovenian: Vložek (steklo tipa 1) z batom (brombutil) in laminatno gumijasto prevleko (brombutil/poliizopren) v večodmernem napolnjenem injekcijskem peresniku iz polipropilena, poliacetala, polikarbonata in akrilonitril butadien stirena.
English: Liraglutide exposure was not studied in patients with body weight >234 kg.
Slovenian: Izpostavljenosti liraglutidu pri bolnikih s telesno maso > 234 kg niso merili.
English: Increased amylase *Hypoglycaemia (based on self-reported symptoms by patients and not confirmed by blood glucose measurements) reported in patients without type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise.
Slovenian: povečana koncentracija amilaze *Hipoglikemija (ugotovljena na osnovi simptomov, ki so jih opazili bolniki, in ni potrjena z meritvami glukoze v krvi) pri bolnikih brez sladkorne bolezni tipa 2, zdravljenih z zdravilom Saxenda v kombinaciji z dieto in telesno vadbo.
English: EXP Discard pen 1 month after first use
Slovenian: EXP Injekcijski peresnik zavrzite 1 mesec po prvi uporabi.
English: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists.
Slovenian: Pri uporabi agonistov receptorjev GLP-1 je bil opažen akutni pankreatitis.
English: Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) analogue with 97% amino acid sequence homology to endogenous human GLP-1.
Slovenian: Liraglutid je acilirani humani analog glukagonu podobnega peptida-1 (GLP-1) s 97 % homologijo zaporedja aminokislin glede na endogeni humani GLP-1.
English: If your pen is already in use, go to step 3 ‘Select your dose'.
Slovenian: Če je injekcijski peresnik že bil uporabljen, glejte korak 3 "Izbira odmerka".
English: Only the dose counter and dose pointer will show how many mg you select per dose.
Slovenian: Le števec odmerka in kazalnik odmerka kažeta, koliko mg izberete na odmerek.
English: BMI (Body Mass Index) is a measure of your weight in relation to your height.
Slovenian: ITM (indeks telesne mase) je razmerje med vašo maso in višino.
English: Patients ≥65 years of age may experience more gastrointestinal effects when treated with Saxenda.
Slovenian: Bolniki, starejši od 65 let, imajo lahko med zdravljenjem z zdravilom Saxenda več neželenih učinkov na prebavilih.
English: There is little experience with this medicine in patients of 75 years and older.
Slovenian: Izkušenj z uporabo tega zdravila pri bolnikih, starih 75 let in več, je malo.
English: Use a calculator to plan the doses as instructed by your doctor or nurse.
Slovenian: Za načrtovanje odmerkov uporabite računalo, v skladu z navodili zdravnika ali medicinske sestre.
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop anti-liraglutide antibodies following treatment with liraglutide.
Slovenian: Glede na morebitne imunogenske lastnosti zdravil, v katerih so beljakovine ali peptidi, se lahko po zdravljenju z liraglutidom pri bolnikih razvijejo protitelesa proti liraglutidu.
English: If you use more Saxenda than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Saxenda, kot bi smeli Če ste uporabili večji odmerek zdravila Saxenda, kot bi smeli, se nemudoma posvetujte z zdravnikom ali odidite v bolnišnico.
English: Pharmacotherapeutic group: Drugs used in diabetes, glucagon-like peptide-1 (GLP-1) analogues.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, analogi glukagonu podobnega peptida1 (GLP-1).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that it is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni "brez natrija".
English: Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or faeces (6% and 5%, respectively).
Slovenian: Samo manjši del aplicirane radioaktivnosti se je v urinu (6 %) ali blatu
English: Events were isolated and the majority resolved during continued treatment with Saxenda.
Slovenian: To so bili posamični primeri in so med nadaljevanjem zdravljenja z zdravilom Saxenda večinoma izzveneli.
English: Diet and exercise
Slovenian: Dieta in telesna vadba
English: • ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
Slovenian: • ≥ 27 kg/m² do < 30 kg/m² (prekomerna telesna masa), ki imajo sočasno vsaj eno z debelostjo povezano bolezen, kot npr. disglikemija (predstopnja sladkorne bolezni (preddiabetes) ali sladkorna bolezen tipa 2), hipertenzija, dislipidemija ali obstruktivna apneja med spanjem.
English: *human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
Slovenian: *analog humanega glukagonu podobnega peptida-1 (GLP-1 - glucagon-like peptide-1), pridobljen s tehnologijo rekombinantne DNA iz Saccharomyces cerevisiae.
English: If an anaphylactic reaction is suspected, liraglutide should be discontinued and treatment should not be restarted (see section 4.3).
Slovenian: V primeru suma na anafilaktično reakcijo je treba zdravljenje z liraglutidom prekiniti in se ga ne sme več uvesti (glejte poglavje 4.3).
English: The estimated time to onset of type 2 diabetes mellitus for patients treated with liraglutide 3.0 mg was 2.7 times longer (with a 95% confidence interval of [1.9, 3.9]), and the hazard ratio for risk of developing type 2 diabetes mellitus was 0.2 for liraglutide versus placebo.
Slovenian: Pri bolnikih, ki so se zdravili z liraglutidom v odmerku 3,0 mg, je bil ocenjeni čas do nastopa sladkorne bolezni tipa 2 2,7-krat daljši (95 % interval zaupanja [1,9; 3,9]), razmerje ogroženosti za tveganje razvoja sladkorne bolezni tipa 2 pa je za liraglutid v primerjavi s placebom znašalo 0,2.
English: Patients with heart failure
Slovenian: Bolniki s srčnim popuščanjem
English: The change in heart rate was reversible upon discontinuation of liraglutide (see section 4.4).
Slovenian: Sprememba frekvence srčnega utripa je bila po ukinitvi liraglutida reverzibilna (glejte poglavje 4.4).
English: Do not use Saxenda after the expiry date which is stated on the pen label and carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na injekcijskem peresniku in na škatli poleg oznake "EXP".
English: Mean baseline HbA1c was 8.7 and had improved after 3 years by 1.2 % in patients assigned to liraglutide and by 0.8 % in patients assigned to placebo.
Slovenian: V izhodišču je bila povprečna vrednost HbA1c 8,7, ki se je po 3 letih izboljšala za do 1,2 % pri bolnikih, ki so prejemali liraglutid in za do 0,8 % pri bolnikih, ki so prejemali placebo.
English: When your pen contains less than 3.0 mg the dose counter stops before 3.0 is shown.
Slovenian: Ko injekcijski peresnik vsebuje manj kot 3,0 mg, se števec odmerka ustavi, preden se pokaže 3,0.
English: The absorption of liraglutide following subcutaneous administration was slow, reaching maximum concentration approximately 11 hours post dosing.
Slovenian: Absorpcija liraglutida po subkutanem odmerku je počasna; največjo koncentracijo doseže približno
English: If the dose counter stops before 3.0 mg, there is not enough solution left for a full dose of 3.0 mg.
Slovenian: Če se števec odmerka ustavi pred 3,0 mg, to pomeni, da ni več dovolj raztopine za celotni odmerek 3,0 mg.
English: An extra dose or increase in dose should not be taken to make up for the missed dose.
Slovenian: Ne sme uporabiti dodatnega odmerka ali povečati odmerka, da bi nadoknadil zamujen odmerek.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.