natgillin/translations-raw huggingface dataset:
• You observe signs of a heart attack which may include chest pain or pain that spreads to the neck and shoulders and down the left arm 
• opazite znakove srčanog udara koji mogu uključivati bol u prsima ili bol koji se širi prema vratu i ramenima te niz lijevu ruku
As a result it may not be necessary to stop breast feeding following a single dose of midazolam. 
Posljedično tome, možda nije potrebno prestati dojiti nakon pojedinačne doze midazolama.
Midazolam is excreted mainly by the renal route (60-80% of the injected dose) and recovered as glucuroconjugated alphahydroxy-midazolam. 
Midazolam se izlučuje uglavnom putem bubrega (60 do 80% injicirane doze) u obliku glukurokonjugiranog alfa-hidroksi-midazolama.
Special attention should be paid to respiratory and cardiovascular functions in intensive care. 
Posebna pozornost u intenzivnoj skrbi treba biti usmjerena na respiratorne i kardiovaskularne funkcije.
• Laryngospasm (tightening of the vocal cords causing difficult and noisy breathing) 
• laringospazam (glasnice se stisnu i prouzroče otežano i šumno disanje)
If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. 
Ako se pražnjenjem želuca ne postigne poboljšanje, potrebno je smanjiti apsorpciju primjenom aktivnog ugljena.
Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum. 
Vrh štrcaljke umetnite u stražnji dio prostora između unutrašnje strane obraza i donjih desni.
Preparing to give this medicine 
Priprema za davanje lijeka
Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution. 
Treba izbjegavati uštrcavanje u laringotrahealni prostor kako bi se spriječila nehotična aspiracija otopine.
Anaesthetics and narcotic analgesics 
Anestetici i opioidni analgetici
The effects of BUCCOLAM may be reduced by medicines such as: 
Učinci BUCCOLAMA mogu biti smanjeni primjenom lijekova kao što su:
Seek medical advice immediately or telephone for an ambulance if the patient experiences the following: 
Odmah potražite savjet liječnika ili pozovite hitnu medicinsku pomoć ako u bolesnika opazite sljedeće:
The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment). 
Drugi sastojci su natrijev klorid, voda za injekciju, kloridna kiselina i natrijev hidroksid (za podešavanje pH).
Medicinal products that induce CYP3A4 
Lijekovi koji induciraju CYP3A4
The free base is a lipophilic substance with low solubility in water. 
Slobodna je baza lipofilna tvar, slabo topljiva u vodi.
Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube. 
Uzmite plastičnu tubu, otkinite nepropusni zatvarač s jedne strane i povucite kapicu.
Midazolam may cause anterograde amnesia. 
Midazolam može uzrokovati anterogradnu amneziju.
BUCCOLAM may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness). 
BUCCOLAM može povećati učinak nekih mišićnih relaksansa (lijekova za opuštanje mišića), npr. baklofena (uzrokuje veću pospanost).
BUCCOLAM is available in cartons containing 4 pre-filled oral syringes/tubes (of the same dose). 
BUCCOLAM je dostupan u kutijama koje sadrže 4 napunjene štrcaljke za usta/tube (iste doze).
Co-administration with protease inhibitors (e.g. Saquinavir and other HIV protease inhibitors) may cause a large increase in the concentration of midazolam. 
Istodobna primjena s inhibitorima proteaze (npr. sakvinavirom i drugim inhibitorima HIV proteaze) može uzrokovati veliko povećanje koncentracije midazolama.
BUCCOLAM is not for intravenous use. 
BUCCOLAM nije za intravensku uporabu.
Alcohol may increase the sedative effects of this medicine and make them very sleepy. 
Alkohol može pojačati umirujuće učinke ovoga lijeka i izazvati da se osjećaju vrlo pospano.
Midazolam overdose can present a threat to life if the patient has pre-existing respiratory or cardiac insufficiency, or when combined with other CNS depressants (including alcohol). 
Predoziranje midazolamom može biti opasno po život ako bolesnik otprije ima respiratornu ili srčanu insuficijenciju ili kada se kombinira s drugim depresorima SŽS-a (uključujući alkohol).
• some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination 
• neki lijekovi koji se koriste za liječenje HIV-a i AIDS-a, npr. sakvinavir, kombinacija lopinavira/ritonavira
Pull the red cap off the tip of the syringe and dispose of it safely. 
Povucite crveni zatvarač vrha štrcaljke i sigurno ga zbrinite.
Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required. 
Nemoćni bolesnici podložniji su učincima benzodiazepina na središnji živčani sustav (SŽS) te stoga u njih mogu biti potrebne manje doze.
Life threatening incidents are more likely in patients with breathing difficulties or heart problems, especially when higher doses of BUCCOLAM are given. 
Životno opasni događaji vjerojatniji su u bolesnika s teškoćama disanja ili srčanim teškoćama, osobito u slučaju primjene većih doza BUCCOLAMA.
BUCCOLAM is used to stop a sudden, prolonged, convulsive, seizure in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age). 
BUCCOLAM se koristi za zaustavljanje iznenadnih, produljenih, konvulzivnih napadaja u dojenčadi, male djece, starije djece i adolescenata (od 3 mjeseca do manje od 18 godina).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
• Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
Anterograde amnesia**, ataxia**, dizziness**, headache**, seizure**, paradoxical reactions** 
Anterogradna amnezija**, ataksija**, omaglica**, glavobolja**, napadaj**, paradoksne reakcije**
Your doctor will prescribe the appropriate dose of BUCCOLAM your child needs, generally according to your child's age. 
Odgovarajuću dozu lijeka BUCCOLAM potrebnu Vašem djetetu liječnik će uvijek propisati prema dobi djeteta.
Following overdose with oral midazolam, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. 
Nakon predoziranja oralnim midazolamom, potrebno je inducirati povraćanje (unutar jednog sata) ako je bolesnik pri svijesti, ili provesti ispiranje želuca uz zaštitu dišnih puteva ako je bolesnik bez svijesti.
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. 
Predoziranje benzodiazepinima obično se manifestira stupnjevima depresije središnjeg živčanog sustava, u rasponu od omamljenosti do kome.
How to give BUCCOLAM 
Kako dati BUCCOLAM
• antibiotics, e.g. erythromycin, clarithromycin 
• antibiotici, npr. eritromicin, klaritromicin
BUCCOLAM is contraindicated in patients with severe hepatic impairment (see section 4.3). 
BUCCOLAM je kontraindiciran u bolesnika s teškim oštećenjem jetrene funkcije (vidjeti dio 4.3).
• The child's breathing slows down or stops e.g. slow or shallow breathing or blue lips 
• djetetovo disanje postane sporo ili prestane, npr. sporo ili plitko disanje ili modre usne
7 days of 600 mg once daily decreased the plasma concentrations of intravenous midazolam by about 60%. 
Primjenjivan 7 dana po 600 mg jedanput na dan, smanjio je plazmatsku koncentraciju intravenskog midazolama za otprilike 60%.
Hence, a careful monitoring of the clinical effects and vital signs is recommended during the use of midazolam with a CYP3A4 inhibitor even after a single dose. 
Stoga se preporučuje pomno praćenje kliničkih učinaka i vitalnih znakova za vrijeme primjene midazolama s inhibitorom CYP3A4 čak i nakon samo jedne doze.
It also exerts a sedative and sleepinducing effect of pronounced intensity, and an anxiolytic and a muscle-relaxant effect. 
Također pokazuje sedativni učinak i izrazito izazivanje sna te anksiolitički i miorelaksirajući učinak.
4.5 Interaction with other medicinal products and other forms of interaction Midazolam is metabolized by CYP3A4. 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Midazolam se metabolizira enzimom CYP3A4.
Midazolam has an anticonvulsant effect. 
Midazolam djeluje antikonvulzivno.
Babies born after this medicine is administered during childbirth can also have poor suckling, breathing difficulties and poor muscle tone at birth. 
Osim toga, u djece rođene kada je tijekom porođaja primijenjen ovaj lijek, mogu se javiti slabo sisanje, teškoće s disanjem i slabi mišićni tonus nakon rođenja.
The absolute bioavailability of oromucosal midazolam is about 75% in adults. 
Apsolutna bioraspoloživost midazolama za oralnu sluznicu u odraslih iznosi 75%.
An updated RMP should be submitted: - At the request of the European Medicines Agency; - 2Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
There are no or limited amount of data from the use of midazolam in pregnant women. 
Nema podataka ili su podaci o primjeni midazolama u trudnica ograničeni.
This medicine must only be used by parents/carers where the child has been diagnosed to have epilepsy. 
Ovaj lijek smiju davati samo roditelji/njegovatelji ako je djetetu dijagnosticirana epilepsija.
The administration of high doses of midazolam in the last trimester of pregnancy or during labour has been reported to produce maternal or foetal adverse reactions (risk of aspiration of fluids and stomach contents during labour in the mother, irregularities in the foetal heart rate, hypotonia, poor suckling, hypothermia and respiratory depression in the new-born infant). 
Zabilježeno je da primjena visoke doze midazolama u zadnjem tromjesečju trudnoće ili tijekom trudova uzrokuje nuspojave u majke ili ploda (rizik od aspiracije tekućina i sadržaja želuca za vrijeme trudova, nepravilnosti u srčanim otkucajima ploda, hipotonija, slabi refleks sisanja, hipotermija i respiratorna depresija u novorođenčeta).
Midazolam is a derivative of the imidazobenzodiazepine group. 
Midazolam je derivat iz skupine imidazobenzodiazepina.
Following oromucosal administration in children the area under the curve ratio for alpha-hydroxy midazolam to midazolam is 0.46. 
Nakon primjene kroz oralnu sluznicu u djece, omjer površine ispod krivulje alfa-hidroksi midazolama i midazolama iznosi 0,46.
Aggression**, agitation**, anger**, confusional state**, euphoric mood**, hallucination**, hostility**, movement disorder**, physical assault** 
Agresija**, agitacija**, ljutnja**, konfuzno stanje **, euforično raspoloženje**, halucinacije**, neprijateljsko raspoloženje**, poremećaj pokreta**, fizički napad**
Inhibitors and inducers of CYP3A4 have the potential to respectively increase and decrease the plasma concentrations and, subsequently, the effects of midazolam thus requiring dose adjustments accordingly. 
Inhibitori i induktori CYP3A4 mogu povisiti i sniziti plazmatske koncentracije lijeka i posljedično učinke samog midazolama, što zahtijeva prilagodbu doze.
This may affect their performance at skilled tasks such as driving, riding a bicycle, or using machines. 
To bi moglo utjecati na bolesnikovu sposobnost izvođenja zadataka koji zahtijevaju vještinu, poput upravljanja vozilom, vožnje bicikla ili rukovanja strojevima.
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken. 
Prilikom postupaka u slučaju predoziranja bilo kojim lijekom, treba voditi računa da se možda radi o uzimanju više tvari.
At 30 and 60 minutes, significant elimination of midazolam has already occurred and therefore the increase in mean Cmax is less pronounced; 1.3 to 1.6 and 1.2 to 1.5 fold respectively. 
Nakon 30 i 60 minuta, značajna eliminacija midazolama već se dogodila pa je stoga porast srednje vrijednosti Cmax mnogo manje izražen: 1,3 do 1,6 puta nakon 30 minuta i 1,2 do 1,5 puta nakon 60 minuta (vidjeti dio 4.2).
• narcotic analgesics (very strong pain killers), e.g. fentanyl 
• narkotički analgetici (vrlo jaka sredstva protiv bolova), npr. fentanil
The effects of BUCCOLAM may be intensified by medicines such as: 
Učinci BUCCOLAMA mogu biti pojačani primjenom lijekova kao što su:
Midazolam is excreted in low quantities (0.6%) in human milk. 
Midazolam se izlučuje u majčino mlijeko u ljudi u malim količinama (0,6%).
Syringe volume 
Volumen štrcaljke
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years). 
Liječenje produljenih, akutnih, konvulzivnih napadaja u dojenčadi, male djece, starije djece i adolescenata (od 3 mjeseca do manje od 18 godina).
Grapefruit juice may increase the sedative effects of this medicine and make them very sleepy. 
Sok od grejpfruta može pojačati umirujuće učinke ovoga lijeka i izazvati da se osjećaju vrlo pospano.
• The child is sick (vomits) and the seizure does not stop within 10 minutes 
• dijete povraća i napadaj ne prestane unutar 10 minuta
The frequency and severity of adverse drug reactions reported for Oromucosal midazolam during published clinical trials were similar to the adverse drug reactions reported in the comparative group using rectal diazepam. 
Učestalost i težina nuspojava zabilježenih u slučaju midazolama za primjenu kroz oralnu sluznicu tijekom objavljenih kliničkih pokusa bile su slične nuspojavama zabilježenim u usporedbenoj skupini u kojoj se primjenjivao rektalni diazepam.
The elimination half-life in cirrhotic patients may be longer and the clearance lower as compared to those in healthy volunteers (see section 4.4). 
Poluvijek eliminacije u bolesnika s cirozom jetre može biti dulji, a klirens niži kad se usporedi s onim u zdravih dobrovoljaca (vidjeti odjeljak 4.4).
In humans, midazolam has been shown to cross the placenta slowly and to enter foetal circulation. 
U ljudi midazolam sporo prolazi kroz placentu i ulazi u fetalnu cirkulaciju.
The effect of CYP3A4 inhibitors may be larger in infants since part of the oromucosal dose is probably swallowed and absorbed in the gastro-intestinal tract. 
Učinak inhibitora CYP3A4 može u dojenčadi biti veći, jer se dio doze primijenjene preko oralne sluznice vjerojatno proguta i apsorbira u gastrointestinalnom traktu.
• The active substance is midazolam 
• Djelatna tvar je midazolam.
• A kidney, liver or heart condition 
• bolest bubrega, jetre ili srca
The mean half-life is greater in obese than in non-obese patients (5.9 versus 2.3 hours). 
Prosječni poluvijek veći je u gojaznih bolesnika u usporedbi s onima normalne težine (5,9 naspram 2,3 sata).
E.g. baclofen. 
Primjer je baklofen.
PHARMACEUTICAL FORM Oromucosal solution Clear colourless solution pH 2.9 to 3.7 
Otopina za usnu sluznicu Bistra, bezbojna otopina pH 2,9 do 3,7
• medicines used to reduce fat in the blood, e.g. atorvastatin 
• lijekovi koji se koriste za smanjenje količine masnoća u krvi, npr. atorvastatin
Therefore, the use of BUCCOLAM in the 3-6 month age group should be limited for use only under the supervision of a health care professional where resuscitation equipment is available and where respiratory function can be monitored and equipment for respiratory assistance, if needed, is available. 
Stoga primjenu lijeka BUCCOLAM u dobnoj skupini 3-6 mjeseci treba ograničiti samo na uporabu pod nadzorom zdravstvenog stručnjaka, tamo gdje je dostupna oprema za oživljavanje i gdje je moguće nadzirati respiratornu funkciju, a u slučaju potrebe, na raspolaganju je oprema za potporu disanja.
Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube. 
Napunjena štrcaljka za usta boje jantara bez igle (polipropilen) s klipom (polipropilen) i zatvaračem vrha (polietilen visoke gustoće) pakirana u zaštitnu plastičnu tubu sa zatvaračem.
• sedative antidepressants (medicines used to treat depression that make you sleepy) 
• sedativni antidepresivi (lijekovi protiv depresije koji Vas čine pospanima) • sedativi (lijekovi koji Vas opuštaju)
• Low blood pressure, slow heart rate, or redness of the face and neck (flushing) 
• nizak krvni tlak, usporeni srčani otkucaji ili crvenilo lica i vrata (navale crvenila)
Keep the oral syringe in the protective plastic tube. 
Štrcaljku za usta čuvati u zaštitnoj plastičnoj tubi.
Alcohol intake should be strongly avoided in case of midazolam administration (see section 4.4). 
Kod primjene midazolama treba izbjegavati unos alkohola (vidjeti dio 4.4).
BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy. 
BUCCOLAM smiju davati samo roditelji/njegovatelji ako je bolesniku dijagnosticirana epilepsija.
Life-threatening incidents are more likely to occur in those with pre-existing respiratory insufficiency or impaired cardiac function, particularly when a high dosage is administered (see section 4.4). 
Za život opasni incidenti vjerojatniji su u onih u kojih već otprije postoji respiratorna insuficijencija ili oštećenje srčane funkcije, osobito prilikom primjene visokih doza (vidjeti dio 4.4).
Very rare: Apnoea**, dyspnea**, laryngospasm**, respiratory arrest** 
Vrlo rijetko: Apneja**, dispneja**, laringospazam**, respiratorni arest**.
The co-administration of midazolam with other sedative/hypnotic medicinal products and CNS depressants, including alcohol, is likely to result in enhanced sedation and respiratory depression. 
Istodobna primjena midazolama s drugim sedativima/hipnoticima i depresorima SŽS-a uključujući alkohol, vjerojatno će uzrokovati povećanu sedaciju i respiratornu depresiju.
• hypnotics (sleep inducing medicines) 
• hipnotici (lijekovi koji izazivaju san)
If you are not sure if any of the above applies to the patient, talk to a doctor or pharmacist before giving this medicine. 
Ako niste sigurni odnosi li se išta od gore navedenog na određenog bolesnika, prije davanja ovog lijeka porazgovarajte s liječnikom ili ljekarnikom.
3 months to < 1 year Yellow 
1 ml od 3 mjeseca do < 1 godine žuta
This medicine should be avoided in patients with a medical history of alcohol or drug abuse. 
Primjenu ovog lijeka treba izbjegavati u bolesnika sa zlouporabom alkohola ili droga u povijesti bolesti.
Shire Services BVBA rue Montoyer 47 
Shire Services BVBA
After oromucosal administration, only systemic clearance will be affected. 
Nakon primjene preko sluznice usta, bit će pogođen samo sistemski klirens.
Plasma clearance of midazolam in children following oromucosal administration is 30 ml/kg/min. 
Plazmatski klirens midazolama u djece nakon primjene kroz usnu sluznicu je 30 ml/kg/min.
Pharmacokinetic interactions with CYP3A4 inhibitors or inducers are more pronounced for oral as compared to oromucosal or parenteral midazolam as CYP3A4 enzymes are also present in the upper gastro-intestinal tract. 
Farmakokinetičke interakcije s inhibitorima CYP3A4 ili njihovim induktorima izraženije su za oralne oblike nego za parenteralni midazolam ili onaj koji se primjenjuje preko sluznice usta, jer su enzimi CYP3A4 prisutni i u gornjem dijelu gastrointestinalnog trakta.
In 4 rectal diazepam controlled studies and one study versus intravenous diazepam, in a total of 688 children, cessation of visible signs of seizures within 10 minutes was observed in 65% to 78% of children receiving oromucosal midazolam. 
U 4 ispitivanja midazolama kontrolirana rektalnom primjenom diazepama te u jednom ispitivanju usporedbe midazolama i intravenskog diazepama provedenim na ukupno 688 djece, u 65% do 78%
• You give too much BUCCOLAM and there are signs of overdose which include: o Drowsiness, tiredness, fatigue o Confusion or feeling disorientated o Absence of knee reflex or a response to a pinch o Breathing difficulties (slow or shallow breathing) o Low blood pressure (giddiness and feeling faint) o Coma 
• primijenili ste previše lijeka BUCCOLAM i postoje znakovi predoziranja koji uključuju: o omamljenost, umor o smetenost ili osjećaj dezorijentiranosti o odsutnost refleksa koljena ili reakcije na štipanje o teškoće s disanjem (sporo ili plitko disanje) o nizak krvni tlak (omaglica i osjećaj nesvjestice)
• antiepileptics, (for treating epilepsy) e.g. phenytoin 
• antiepileptici (za liječenje epilepsije), npr. fenitoin
Severe respiratory insufficiency 
Teška respiratorna insuficijencija.
Fentanyl may reduce midazolam clearance. 
Fentanil može smanjiti klirens midazolama.
Grapefruit juice reduces the clearance of midazolam and potentiates its action. 
Sok od grejpfruta smanjuje klirens midazolama i potencira njegovo djelovanje.
If the child is sick (vomits) 
Ako dijete povraća
Midazolam is hydroxylated by the cytochrome P4503A4 isozyme and the major urinary and plasma metabolite is alpha-hydroxy-midazolam. 
Midazolam se hidroksilira pomoću CYP P4503A4 izozima, a većina mokraćnog i plazmatskog metabolita je alfa-hidroksi midazolam.
The elimination half-life in patients with chronic renal failure is similar to that in healthy volunteers. 
Oštećenje bubrega Poluvijek eliminacije u bolesnika s kroničnim zatajenjem bubrega sličan je onome u zdravih dobrovoljaca.
• antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, pozaconazole 
• antifungici (lijekovi protiv gljivica), npr. ketokonazol, vorikonazol, flukonazol, itrakonazol,
• antihistamines (to treat allergies). 
• anestetici (za ublažavanje bolova) • antihistaminici (za liječenje alergija).
Midazolam is highly lipophilic and distributes extensively. 
Midazolam je visoko lipofilan te se naširoko raspodjeljuje u organizmu.
• Severe breathing difficulties e.g. slow or shallow breathing or blue lips. 
• Teške poteškoće u disanju, primjerice sporo ili plitko disanje ili modre usne.
Therefore, the clinical effects may be stronger and prolonged, hence careful monitoring of the clinical effects and vital signs is recommended following administration of midazolam in patients with hepatic impairment (see section 4.4). 
Klinički učinci mogu stoga biti jači i produljeni, pa se nakon primjene midazolama u bolesnika s oštećenjem jetrene funkcije preporučuje pomno praćenje kliničkih učinaka i vitalnih znakova (vidjeti dio 4.4).
1000 Brussels Belgium 
rue Montoyer 47 1000 Brussels Belgija
How to store BUCCOLAM 
Kako čuvati BUCCOLAM
The full amount of solution should be inserted slowly into the space between the gum and the cheek. 
Punu količinu otopine treba polako uštrcati u prostor između desni i obraza.
Medicinal product interactions following oromucosal administration of midazolam are likely to be similar to those observed after intravenous midazolam rather than oral administration. 
Interakcije lijekova nakon primjene midazolama preko usne sluznice, bit će vjerojatno slične onima opaženim nakon intravenske, a ne peroralne primjene midazolama.
Additionally, in 2 of the studies, cessation of visible signs of seizures within 10 minutes without recurrence within 1 hour after administration was observed in 56% to 70% of children. 
minuta bez ponavljanja unutar 1 sata nakon primjene, opažen je u 56% do 70% djece.
The elimination half-life is longer in patients with congestive heart failure compared with that in healthy subjects (see section 4.4). 
Poluvijek eliminacije dulji je u bolesnika s kongestivnim zatajenjem srca u usporedbi s onim u zdravih ispitanika (vidi odjeljak 4.4).
Uncommon: ≥ 1/1,000 to < 1/100 
Manje često: ≥ 1/1000 i < 1/100 Vrlo rijetko: < 1/10 000