natgillin/translations-raw huggingface dataset:
Anaphylactic reaction including dyspnoea, hypotension and shock. 
Anafilaktična reakcija, vključno z dispnejo, hipotenzijo in šokom.
AMGLIDIA has moderate influence on the ability to drive and use machines since glibenclamide may increase the risk of hypoglycaemia. 
Zdravilo AMGLIDIA ima zmeren vpliv na sposobnost vožnje in upravljanja strojev, saj lahko glibenklamid poveča tveganje za hipoglikemijo.
Such low blood sugar should be managed by taking sugar by mouth followed by a snack or meal. 
Take nizke ravni sladkorja v krvi je treba uravnavati s peroralnim jemanjem sladkorja, čemur sledi prigrizek ali obrok.
Rifampicin used to treat infections including tuberculosis 
Rifampicin, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo
Adults and elderly 
Odrasli in starejši bolniki
After such a severe episode of hypoglycaemia, the child and family should see the child's doctor to check the appropriateness of the dose of glibenclamide suspension. 
Po tako hudem dogodku hipoglikemije morajo otrok in družinski člani obiskati otrokovega zdravnika ter se z njim posvetovati o ustreznosti odmerka suspenzije glibenklamida.
Diabetes symptoms may reappear and may lead to a serious disturbance of the body's metabolism with high blood levels of ketones (ketoacidosis), dehydration and disturbance of the balance of acids in the body. 
Simptomi sladkorne bolezni se lahko ponovijo in povzročijo resne motnje presnove v telesu z visokimi ravnmi ketonov v krvi (ketoacidoza), dehidracijo in motnjami ravnovesja kislin v telesu.
Before each administration, it should be verified that the correct strength and syringe are used. 
Pred vsakim dajanjem zdravila je treba preveriti, ali se uporabljata ustrezna jakost in brizga.
The elimination half-lives were similar for the two suspensions (almost 8 hours) and a little shorter than those observed with the crushed Daonil tablets. 
Razpolovni čas izločanja je bil za obe suspenziji podoben (skoraj 8 ur) in nekoliko krajši od razpolovnega časa pri zdrobljenih tabletah zdravila Daonil.
In pregnant women insulin is recommended for blood sugar control. 
Pri nosečnicah se priporoča jemanje insulina za nadzor sladkorja v krvi.
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Therefore, glibenclamide should be administered at least 4 hours prior to colesevelam. 
Zato je treba glibenklamid dajati vsaj 4 ure pred kolesevelamom.
In case of inability of food or beverage intake, the child should go to emergency department to get an insulin and glucose perfusion until vomiting stops. 
Če otrok ni sposoben zaužiti hrane ali pijače, ga je treba odpeljati na urgentni oddelek, da prejema infuzijo insulina in glukoze, dokler se bruhanje ne ustavi.
If ketonuria is detected, you must inject insulin immediately according to the procedure defined beforehand with your child's doctor and contact him/her or his/her team for advice. 
Če ugotovite ketonurijo, morate takoj injicirati insulin v skladu s postopkom, ki ga je pred tem določil zdravnik vašega otroka, in se posvetovati z zdravnikom.
Sometimes, blood-glucose concentration will fall even though the patient is on a fixed dose of AMGLIDIA. 
Včasih se bo koncentracija glukoze v krvi zmanjšala, čeprav je bolnik na fiksnem odmerku zdravila AMGLIDIA.
The oral syringe in the carton should be used only with this medicine. 
Peroralno brizgo v škatli lahko uporabljate samo s tem zdravilom.
If it is necessary to prescribe this medicinal product, screening should be conducted for the occurrence of any haemolysis. 
Če je treba predpisati to zdravilo, je treba izvesti preverjanje glede pojavljanja kakršne koli hemolize.
If the child does not suck, slowly press the plunger of the syringe so that the suspension trickles into the mouth. 
Če otrok ne sesa, počasi potisnite bat brizge, tako da začne suspenzija kapljati v usta.
Women of childbearing potential planning a pregnancy should be switched from oral glibenclamide to insulin. 
Ženske v rodni dobi, ki načrtujejo nosečnost, morajo preiti s peroralnega glibenklamida na insulin.
The same child had a transient and minimal ASAT 73 IU/L, and ALAT 42 IU/L increased (normal range below 60 and 40 respectively). 
Isti otrok je imel prehodno povišani najnižji vrednosti AST in ALT, 73 i.e./l oziroma 42 i.e./l (normalni vrednosti sta 60 oziroma 40).
Transient visual disturbances (blurred vision or accommodation disorder), especially early in treatment, with or without glycaemic variation. 
Prehodne motnje vida (zamegljen vid ali motnja akomodacije), zlasti na začetku zdravljenja, z glikemično spremembo ali brez nje.
Tell your doctor or pharmacist if you notice any of the following side effects: - Skin rash: itching, nettle rash (urticarial), allergic skin reaction, blistering of the skin, skin inflammation. 
Obvestite zdravnika ali farmacevta, če opazite katerega od naslednjih neželenih učinkov: - kožni izpuščaji, srbečica, koprivnica (urtikarija), alergijska kožna reakcija, mehurjenje, vnetje kože;
Head to head comparative pharmacokinetic data following the application of glibenclamide suspension and micronised tablets are not available. 
Neposredno primerljivi farmakokinetični podatki po uporabi suspenzije glibenklamida in mikroniziranih tablet niso na voljo.
Transitory diarrhea, vomiting and abdominal pain and dyspepsia Two children had abdominal pain (one with transient diarrhea and vomiting during the same episode) that were considered related to the medicinal product. 
Prehodna driska, bruhanje in bolečine v trebuhu ter dispepsija Dva otroka sta imela bolečine v trebuhu (eden s prehodno drisko in bruhanjem v isti epizodi), za katere se je štelo, da so povezane z zdravilom.
Benzoic acid and benzoates (sodium benzoate) 
Benzojska kislina in benzoati (natrijev benzoat)
Patients can be discharged when no longer requiring insulin treatment, when stable on a combination of AMGLIDIA and insulin or when stable on insulin alone. 
Bolnike je mogoče odpustiti iz bolnišnice, ko ne potrebujejo več zdravljenja z insulinom, so stabilni na kombinaciji z zdravilom AMGLIDIA ali so stabilni na samostojnem insulinu.
If you have any further questions on the use of this medicine, ask the doctor of your child or pharmacist. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom svojega otroka ali farmacevtom.
As generally recommended in such situations, if vomiting occurs less than 30 minutes following administration of AMGLIDIA, a new dose can be given. 
Kot se na splošno priporoča v takih primerih, se lahko v primeru, če se bruhanje pojavi prej kot v 30 minutah po zaužitju zdravila AMGLIDIA, da nov odmerek.
The syringe must be rinsed thoroughly with water, wiped dry after each use and replaced back into the medicine's carton. 
Brizgo temeljito očistite z vodo, jo po vsaki uporabi obrišite do suhega in ponovno namestite v škatlo zdravila.
Seventy-five patients (93%) remained on sulphonylurea alone at most recent follow-up and 6/81(7%) were on sulphonylurea and daily insulin. 
Petinsedemdeset bolnikov (93 %) bolnikov se je pri zadnjem spremljanju še vedno zdravilo samo s sulfonilsečnino, 6/81 (7 %) bolnikov pa se je zdravilo s sulfonilsečnino in vsakodnevnim jemanjem insulina.
Bioavailability studies have demonstrated that nonmicronised tablets provide serum glibenclamide concentrations that are not bioequivalent to those from micronised tablets. 
S študijami biološke uporabnosti je bilo dokazano, da nemikronizirane tablete povzročijo koncentracije glibenklamida v serumu, ki niso biološko enakovredne tistim iz mikroniziranih tablet.
Skin rash, pruritus, urticaria, allergic skin reaction. 
Kožni izpuščaji, srbečica, koprivnica, alergijska kožna reakcija.
Glibenclamide may increase ciclosporin plasma concentration and potentially lead to its increased toxicity. 
Glibenklamid lahko poveča koncentracijo ciklosporina v plazmi in poveča njegovo toksičnost.
Plasma clearance of glibenclamide may be prolonged in patients suffering from liver disease. 
Izločanje glibenklamida iz plazme se lahko pri bolnikih z boleznijo jeter podaljša.
Microvascular complications were reported in 7/81(9%) patients; there were no macrovascular complications. 
Pri 7/81 (9 %) bolnikih so poročali o mikrovaskularnih zapletih; do makrovaskularnih zapletov pa ni prišlo.
Bosentan used to treat high blood pressure in the blood vessels between the heart and the lungs. 
Bosentan, ki se uporablja za zdravljenje visokega krvnega tlaka v krvnih žilah med srcem in pljuči
Care should be taken when prescribing and administering AMGLIDIA to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL). 
Pri predpisovanju in dajanju zdravila AMGLIDIA je potrebna pazljivost, da se preprečijo napake pri odmerjanju zaradi zamenjave med miligrami (mg) in mililitri (ml).
Blood-glucose level must be checked immediately and AMGLIDIA taken as soon as possible. 
Takoj je treba preveriti raven glukoze v krvi in čim prej vzeti zdravilo AMGLIDIA.
You should check your child's blood sugar (capillary blood sugar). 
Preveriti morate raven sladkorja v krvi svojega otroka (sladkor v kapilarni krvi).
Higher doses have occasionally been reported in the literature with doses as high as 2.8 mg/kg/day without undesirable effects and with full transfer off insulin. 
Občasno so v literaturi poročali o večjih odmerkih do 2,8 mg/kg/dan brez neželenih učinkov in s popolno prekinitvijo insulina.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu.
Population pharmacokinetic approach was used to compare steady state concentrations following 0.9 mg twice daily in children with body weights between 10 - 30 kg and 1.25 mg twice daily in adults. 
Farmakokinetični pristop k populaciji je bil uporabljen za primerjavo koncentracij v stanju dinamičnega ravnovesja po zaužitju 0,9 mg dvakrat dnevno pri otrocih s telesno maso od 10 do 30 kg in 1,25 mg dvakrat dnevno pri odraslih.
A large international long-term term study of treatment for neonatal diabetes due to KCNJ11 mutations is ongoing and results were reported in 81 patients of the 90 patients originally included with a median [interquartile range] follow-up duration of 10.2 years [9.3-10.8 years]. 
Trenutno se izvaja obsežna mednarodna dolgoročna študija o zdravljenju sladkorne bolezni pri novorojenčkih zaradi mutacij KCNJ11, o rezultatih pa so poročali pri 81 bolnikih od izvirno vključenih 90 bolnikov, pri čemer je bila mediana (interkvartilni razpon) trajanja sledenja 10,2 leta (9,3-10,8 leta).
Stimulation of insulin secretion by glibenclamide in response to a meal is of major significance. 
Spodbujanje izločanja insulina z glibenklamidom kot odziv na obrok je zelo pomembno.
The values for maximum plasma concentrations (Cmax) were similar for the two suspensions (201.71 ± 71.43 ng/mL for the 6 mg/mL suspension and 206.93 ± 67.33 ng/mL for the 0.6 mg/mL suspension). 
Vrednosti za najvišje koncentracije v plazmi (Cmax) so bile podobne za obe suspenziji (201,71 ± 71,43 ng/ml za 6 mg/ml suspenzijo in 206,93 ± 67,33 ng/ml za 0,6 mg/ml suspenzijo).
Clarithromycin is an antibiotic used to treat certain infections 
Klaritromicin je antibiotik, ki se uporablja za zdravljenje nekaterih okužb
If your child starts to become pale, sweating, has irregular heart rhythm or seems disoriented, confused or unresponsive, these may be signs that the child's blood sugar is too low ; you should first solve the situation as explained below and you should then talk to your child's doctor to adapt AMGLIDIA's dose. 
Če vaš otrok postaja bled, se poti, ima neenakomeren srčni utrip ali se zdi, da je dezorientiran, zmeden ali neodziven, so to lahko znaki prenizke ravni sladkorja v krvi vašega otroka; najprej sledite spodaj opisanemu postopku, nato pa se posvetujte z zdravnikom svojega otroka glede prilagoditve odmerka zdravila AMGLIDIA.
Oral glucose tolerance tests and intravenous glucose tolerance tests revealed good insulin response to glucose and maintained incretin effect after ten years. 
Obremenilni test z glukozo ( OGTT) in intravenski glukozni tolerančni test (IVGTT) sta pokazala dober odziv insulina na glukozo in ohranjanje inkretinskega učinka po desetih letih.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Interactions of AMGLIDIA with other medicines are presented in the table below: 
Medsebojno delovanje zdravila AMGLIDIA z drugimi zdravili je predstavljeno v spodnji preglednici.
Administration through a feeding tube should be avoided. 
Izogibati se je treba dajanju zdravila skozi cevko za hranjenje.
G6PD is an enzyme evolved in sugar metabolism. 
G6PD je encim, ki sodeluje pri presnovi sladkorja.
AMGLIDIA is used in newborns, infants and children to treat diabetes that occurs at birth (known as neonatal diabetes mellitus). 
Zdravilo AMGLIDIA se uporablja pri novorojenčkih, dojenčkih in otrocih za zdravljenje sladkorne bolezni, ki se pojavi ob rojstvu (znane kot neonatalni diabetes mellitus).
Postprandial responses involving secretion of insulin and peptide-C continue to be enhanced after at least 6 months of treatment and even over many years in the case of neonatal diabetes by potassium channel disorders. 
Odzivi po obroku, med katere spadata izločanje insulina in C-peptida, se krepijo vsaj še 6 mesecev po zdravljenju in celo več let v primeru sladkorne bolezni pri novorojenčkih z motnjami delovanja kalcijevih kanalčkov.
Do not lay the child down directly after administration. 
Otroka ne odstavite takoj po dajanju zdravila.
Hypereosinophilia, leucopenia, mild or severe thrombocytopenia, which can lead to purpura. 
Hipereozinofilija, levkopenija, blaga ali huda trombocitopenija, ki lahko povzroči purpuro.
From data published in the literature, treatment with sulfonylurea is reported to be successful in approximately 90% of the patients with neonatal diabetes associated with K-ATP channel mutations. 
Na podlagi podatkov, objavljenih v literaturi, so poročali, da je zdravljenje s sulfonilsečninami uspešno pri približno 90 % bolnikih z neonatalno sladkorno boleznijo, povezano z mutacijami kanalčka K-ATP.
The most serious adverse reaction is hypoglycemia (see section 4.4). 
Najresnejši neželeni učinek je hipoglikemija (glejte poglavje 4.4).
Contents of the pack and other information What AMGLIDIA contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo AMGLIDIA
Published data from 11 glibenclamide-treated mothers indicate that glibenclamide is not excreted in human milk and hypoglycemia in the breast-fed newborns was not reported. 
Objavljeni podatki o 11 materah, zdravljenih z glibenklamidom, kažejo, da se glibenklamid ne izloča v materino mleko, in pri novorojenčkih, ki so jih matere dojile, niso poročali o hipoglikemiji.
Amglidia is not bioequivalent with (crushed) tablets containing the same amount of glibenclamide. 
Zdravilo AMGLIDIA ni biološko enakovredno (zdrobljenim) tabletam enake količine glibenklamida.
Symptomatic measures were taken and the situation resolved. 
Sprejeti so bili simptomatski ukrepi in težave so bile odpravljene.
The food effect on the speed or the level of absorption of glibenclamide oral suspension has not been investigated. 
Učinek hrane na hitrost ali raven absorpcije peroralne suspenzije glibenklamida ni bil raziskan.
Depending on the volume to be administered orally, there are two types of oral syringes, graduated up to 1 mL or up to 5 mL. 
Glede na volumen, ki ga je treba dati peroralno, obstajata dve vrsti peroralnih brizg, tj. graduirane do 1 ml ali do 5 ml.
Your doctor will prescribe the specific presentation and strength including the particular syringe you should use. 
Zdravnik bo predpisal določeno obliko in jakost zdravila, vključno z ustrezno brizgo, ki jo morate uporabljati.
However, close monitoring of blood-glucose is required in all cases (please also refer to recommendations given under the heading “dose omission” further below) and adequate measures to restore euglycemia (e. g. application of a third daily AMGLIDIA dose or insulin) must be taken. 
Vendar so v vseh primerih potrebni skrbno spremljanje ravni glukoze v krvi (glejte tudi priporočila pod spodnjim naslovom »Izpuščen odmerek«) in ustrezni ukrepi za ponovno vzpostavitev normalne ravni glukoze (npr. uporaba tretjine dnevnega odmerka zdravila AMGLIDIA).
ACE inhibitors (used to treat hypertension) (such as captopril and enalapril) 
Zaviralci ACE (ki se uporabljajo za zdravljenje hipertenzije) (kot sta kaptopril in enalapril)
Breast-feeding seems to be compatible, but as a precautious measure monitoring of the fully breast-fed infant's blood sugar level is advisable. 
Zdi se je, da je dojenje združljivo z zdravilom, vendar se kot previdnostni ukrep priporoča spremljanje ravni sladkorja v krvi pri dojenčkih, ki se v celoti dojijo.
As shown in the literature and in the clinical studies performed with AMGLIDIA, the average daily dose is expected to be around 0.2 to 0.5 mg/kg/day in most of the patients suffering from neonatal diabetes. 
Kot so pokazali v literaturi in kliničnih študijah, izvedenih z zdravilom AMGLIDIA, je pričakovati, da bo povprečni dnevni odmerek pri večini bolnikov z neonatalno sladkorno boleznijo približno od 0,2 do
The educational material is aimed at increasing awareness about the four presentations available (two strengths of the product, each containing either a 1mL or a 5mL syringe) and at minimising the risk of hypoglycaemia in case of mix-ups of the different presentations. 
Izobraževalno gradivo je namenjeno ozaveščanju o štirih razpoložljivih oblikah zdravila (dve jakosti zdravila, pri čemer vsaka vsebuje 1 ml ali 5 ml brizgo) in zmanjševanju tveganja hipoglikemije v primeru zamenjave različnih oblik zdravila.
If there is major vomiting, a fast-acting insulin should be used to treat the patient until vomiting stops. 
Pri močnem bruhanju je treba za zdravljenje bolnika uporabiti hitro delujoč insulin, dokler se bruhanje ne ustavi.
MedDRA system organ class 
Organski sistem MedDRA
In those patients, treatment should be started at the lowest dose and dosage levels strictly followed, to avoid hypoglycaemic reactions (see section 4.4). 
Take bolnike je treba začeti zdraviti z najmanjšim odmerkom in strogo upoštevati ravni odmerka, da se preprečijo hipoglikemične reakcije (glejte poglavje 4.4).
Potentiate or weaken the effect of coumarin derivatives 
Potenciranje ali slabitev učinka derivatov kumarina
The mechanisms of action proposed for this effect include stimulation of insulin release by beta-cells of the pancreas. 
Mehanizmi delovanja, ki so domnevno odgovorni za ta učinek, vključujejo spodbujanje sproščanja insulina iz celic beta trebušne slinavke.
During titration period patients' capillary blood-glucose concentration should continue to be monitored four times a day and at bedtime, as insulin requirements may continue to fall, or AMGLIDIA may need to be titrated. 
Med obdobjem titracije je treba nadaljevati s spremljanjem bolnikove koncentracije glukoze v kapilarni krvi štirikrat na dan in pred spanjem, saj se lahko potreba po insulinu nenehno manjša ali pa je treba titrirati zdravilo AMGLIDIA.
If your child's capillary blood sugar exceeds 3 g/L (or 300 mg/dL or 16.5 mmol/L), check for the presence of ketonuria with a finger stick or urine stick tests according to your child's doctor recommendations. 
Če raven sladkorja v kapilarni krvi vašega otroka presega 3 g/l (ali 300 mg/dl ali 16,5 mmol/l), z merilnikom sladkorja v krvi ali merilnikom za ugotavljanje sladkorja v urinu v skladu s priporočili otrokovega zdravnika preverite, ali se je pojavila ketonurija.
Other medicines and AMGLIDIA 
Druga zdravila in zdravilo AMGLIDIA
Close monitoring of blood-glucose by the patient's family must be continued until the family and the physician, if he/she had to be contacted, are certain that the patient is out of danger. 
Družinski člani bolnika morajo še naprej skrbno spremljati raven glukoze v krvi, dokler se oni in zdravnik, če se morajo obrniti nanj, ne prepričajo, da je bolnik zunaj nevarnosti.
AMGLIDIA contains sodium and benzoate salt 
Zdravilo AMGLIDIA vsebuje natrij in benzoatno sol
Oxypentifylline used to improve peripheral blood flow 
Oksipentifilin, ki se uporablja za izboljšanje perifernega krvnega obtoka
Adrenaline (epinephrine) and other sympathomimetic agents (used to treat serious allergic reaction, cardiovascular arrest, asthma) 
Adrenalin (epinefrin) in drugi simpatikomimetiki (ki se uporabljajo za zdravljenje hudih alergijskih reakcij, srčno-žilnih motenj in astme)
If very low blood sugar occurs that affects consciousness, emergency services should be called and an intravenous glucose injection performed. 
V primeru zelo nizke ravni sladkorja v krvi, ki vpliva na zavest, pokličite službo za nujno pomoč, saj je otroku treba intravensko injicirati glukozo.
Put the syringe into the child mouth and push the plunger to slowly administer the medicine into the mouth. 
Vstavite brizgo v otrokova usta in potisnite bat ter počasi dajajte zdravilo v usta.
Therefore, to avoid hypoglycaemia, consideration should be given to reducing the dose of AMGLIDIA or stopping treatment. 
Da se v takih primerih prepreči hipoglikemija, je treba razmisliti o zmanjšanju odmerka zdravila AMGLIDIA ali prekinitvi zdraljenja.
Patients with complications were older at age of transfer to sulfonylurea than those without complications (median age at transfer: 20.5 v 4.1 years, p=0.0005). 
Bolniki, pri katerih je prišlo do zapletov, so bili pri prehodu na sulfonilsečnino starejši od tistih, pri katerih ni prišlo do zapletov (mediana starost od prehodu 20,5 v primerjavi s 4,1 leta, p = 0,0005).
Tell the doctor if you know that your child is affected by G6PD deficiency and contact him/her if you notice that your child is pale as compared to usually. 
Če veste, da vašemu otroku primanjkuje encima G6PD, o tem obvestite zdravnika in se obrnite nanj, če opazite, da je vaš otrok bolj bled kot ponavadi.
If there is a clear reduction in insulin requirement at this dose of 2 mg/kg/day (reduction in insulin to at least 60% of pre-AMGLIDIA dose), then it is worth continuing a higher dose of AMGLIDIA over a prolonged period of time in selected cases. 
V primeru očitnega zmanjšanja potrebe po insulinu pri odmerku 2 mg/kg/dan (zmanjšanje odmerka insulina na vsaj 60 % odmerka pred začetkom dajanja zdravila AMGLIDIA) je v izbranih primerih priporočljivo nadaljnje dajanje večjega odmerka zdravila AMGLIDIA za daljše obdobje.
Anabolic steroids and male sex hormones (such as testosterone enanthate) (used to treat testosterone deficiency) 
Anabolni steroidi in moški spolni hormoni (kot je testosteron enantat) (ki se uporabljajo za zdravljenje pomanjkanja testosterona)
Increased toxicity of ciclosporin 
Večja toksičnost ciklosporina
If a new presentation of AMGLIDIA is prescribed by your doctor, return back your previous presentation and syringe to your pharmacist to avoid mixing up of the syringes. 
Če vam zdravnik predpiše drugo obliko zdravila AMGLIDIA, vrnite prejšnjo obliko zdravila in brizgo farmacevtu, da ne bi zamešali brizg.
In case of a partial response on lower doses, as shown by reduced insulin requirements, a further dose increase up to 2.8 mg/kg/day may be tried in selected cases. 
V primeru delnega odziva na manjše odmerke, dokazanega z zmanjšano potrebo po insulinu, se lahko v izbranih primerih poskusi z nadaljnjim povečanjem odmerka do 2,8 mg/kg/dan.