FrancophonIA/ELRC3.0 huggingface dataset:
English: Maximum plasma concentration is reached within 30 minutes in children.
Croatian: Maksimalna plazmatska koncentracija u djece postiže se unutar 30 minuta.
English: Standard doses are indicated below:
Croatian: Doziranje Standardne doze navedene su ispod:
English: Midazolam may be used during pregnancy if clearly necessary.
Croatian: Midazolam se može upotrebljavati tijekom trudnoće ako je to prijeko potrebno.
English: This is due to an increase of approximately 50% in the volume of distribution corrected for total body weight.
Croatian: To je zbog povećanja od približno 50% u volumenu raspodjele koji je korigiran za ukupnu tjelesnu težinu.
English: Depending on age, your child will have received one of the following doses, in specifically colour labelled packaging:
Croatian: Ovisno o dobi, Vaše će dijete primiti jednu od sljedećih doza iz pakiranja označenih različitim bojama:
English: • Difficulty co-ordinating muscles
Croatian: • teškoće s koordinacijom mišića
English: Ask a doctor, pharmacist or nurse to show you how to take or administer this medicine.
Croatian: Zamolite liječnika, ljekarnika ili medicinsku sestru da Vam pokaže kako uzeti ili primijeniti ovaj lijek.
English: For detailed instructions on how to administer the medicinal product, see section 6.6.
Croatian: Za detaljne upute kako primijeniti ovaj lijek vidjeti dio 6.6.
English: Do not give more than one dose.
Croatian: Nemojte davati više od jedne doze.
English: Children younger than 3 months: BUCCOLAM should not be given to children younger than 3 months since there is not enough information in this age group.
Croatian: Djeca mlađa od 3 mjeseca: BUCCOLAM se ne smije davati djeci mlađoj od 3 mjeseca jer za tu dobnu skupinu ne postoji dovoljno podataka.
English: Altered elimination of midazolam
Croatian: Promijenjena eliminacija midazolama
English: Do not use this medicine if the packaging has been opened or damaged.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje otvoreno ili oštećeno.
English: Exposure following a second dose in the same seizure episode Simulated exposure data show that the overall AUC approximately doubles when a second dose is administered at 10, 30 and 60 minutes following the first dose.
Croatian: Izloženost nakon druge doze u istoj epizodi konvulzivnih napadaja Simulirani podaci o izloženosti pokazuju da se cjelokupni AUC približno udvostručuje kad se druga doza primijeni 10, 30 i 60 minuta nakon prve doze.
English: Flumazenil may be useful as an antidote.
Croatian: Flumazenil može biti koristan kao antidot.
English: Even though small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to stop breast-feeding.
Croatian: Iako male količine BUCCOLAMA mogu prijeći u majčino mlijeko, možda nije potrebno prekinuti dojenje.
English: Other medicines and BUCCOLAM
Croatian: Drugi lijekovi i BUCCOLAM
English: Paediatric patients aged 3 to 6 months
Croatian: Pedijatrijski bolesnici u dobi od 3 do 6 mjeseci
English: Less than 1% of the dose is recovered in urine as unchanged medicinal product..
Croatian: Manje od 1% doze izluči se u mokraći kao nepromijenjeni lijek.
English: • You're unable to empty the syringe or you spill some of the contents
Croatian: • ne možete isprazniti štrcaljku ili Vam se izlio dio sadržaja
English: The terminal half-life decreased by about 50-60%.
Croatian: Terminalni poluvijek se smanjio za otprilike 50-60%.
English: Tell your doctor or pharmacist if the patient is taking, or has recently taken, or might take any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika ako bolesnik uzima, nedavno je uzimao ili bi mogao uzeti bilo koje druge lijekove.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: • Do not give the patient another dose of BUCCOLAM.
Croatian: • Nemojte djetetu davati drugu dozu BUCCOLAMA.
English: • An allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (listed in section 6)
Croatian: • alergiju na midazolam, benzodiazepine (kao što je diazepam) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: The initial and terminal elimination half-lives are 27 and 204 minutes, respectively.
Croatian: Početni poluvijek eliminacije iznosi 27 minuta, a završni 204 minute.
English: What you need to know before you give BUCCOLAM
Croatian: Što morate znati prije nego počnete davati BUCCOLAM
English: If the patient who will be given this medicine is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask a doctor for advice before taking this medicine.
Croatian: Ako je bolesnica koja će primiti lijek trudna ili doji, misli da bi mogla biti trudna ili planira imati dijete, obratite se liječniku za savjet prije nego što uzme ovaj lijek.
English: Approximately 96-98% of midazolam is bound to plasma proteins.
Croatian: Približno 96-98% midazolama veže se na proteine plazme.
English: • Reduced alertness
Croatian: • smanjena budnost
English: Support your child's head with something soft, such as a cushion or your lap.
Croatian: Poduprite djetetovu glavu nečim mekim, kao što je jastuk ili Vaše krilo.
English: • The seizure does not stop within 10 minutes
Croatian: • napadaj ne prestane unutar 10 minuta
English: The information on how to give this medicine is also shown on the tube label.
Croatian: Upute za primjenu ovog lijeka prikazane su i na naljepnici tube.
English: • If the seizure does not stop within 10 minutes, call an ambulance.
Croatian: • Ako napadaj ne prestane unutar 10 minuta od primjene pozovite hitnu medicinsku pomoć.
English: Do not give BUCCOLAM if the patient has:
Croatian: Nemojte bolesniku davati BUCCOLAM ako bolesnik ima:
English: • Muscle spasms and muscle tremors (shaking of your muscles that you cannot control)
Croatian: • grčevi mišića i tremor mišića (drhtanje mišića koje ne možete kontrolirati)
English: The risk for new-born infants should be taken into account in the event of administration of midazolam in the third trimester of pregnancy.
Croatian: Rizik za novorođenčad treba uzeti u obzir u slučaju primjene midazolama u trećem tromjesečju trudnoće.
English: Do not give more than the amount of medicine prescribed by a doctor for the patient.
Croatian: Nemojte dati lijek u količini većoj od one koju je liječnik propisao bolesniku.
English: • Heart attack.
Croatian: • Srčani udar.
English: Keep the syringe to show to the ambulance staff or doctor.
Croatian: Sačuvajte štrcaljku kako biste je pokazali osoblju hitne pomoći ili liječniku.
English: Respiratory depression occurs at a rate of up to 5%, although this is a known complication of convulsive seizures as well as being related to midazolam use.
Croatian: Respiratorna depresija javlja se u stopi do 5% iako je to poznata komplikacija konvulzivnih napadaja a također i komplikacija koja se povezuje s primjenom midazolama.
English: Each syringe is for single use only.
Croatian: Svaka je štrcaljka samo za jednokratnu uporabu.
English: Giving high doses of BUCCOLAM during the last 3 months of pregnancy can cause abnormal heart beat in the unborn child.
Croatian: Primjena velikih doza BUCCOLAMA tijekom 3 zadnja mjeseca trudnoće može prouzročiti nenormalne otkucaje srca nerođenog djeteta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2011
Croatian: Datum prvog odobrenja: 5. rujna 2011.
English: Midazolam is almost entirely eliminated by biotransformation.
Croatian: Biotransformacija Midazolam se gotovo potpuno eliminira biotransformacijom.
English: No data on exposed pregnancies are available for the first two trimesters of pregnancy.
Croatian: Nema podataka o izloženosti u trudnoći tijekom prva dva tromjesečja trudnoće.
English: BUCCOLAM may make the patient sleepy, forgetful or affect their concentration and co-ordination.
Croatian: BUCCOLAM može kod bolesnika izazvati pospanost, zaboravnost ili može utjecati na njegovu koncentraciju i koordinaciju.
English: Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
Croatian: Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
English: • Sleepiness or losing consciousness
Croatian: • pospanost ili gubljenje svijesti.
English: Pharmacotherapeutic group: Psycholeptics, benzodiazepine derivatives ATC code: N05CD08.
Croatian: Farmakoterapijska skupina: psiholeptici, derivati benzodiazepina ATK oznaka: N05CD08.
English: If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side.
Croatian: Ako je potrebno (za veće volumene i/ili manje bolesnike), približno polovicu doze treba polako uštrcati u jednu stranu usta, a zatim drugu polovicu polako u drugu stranu usta.
English: A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2).
Croatian: U slučaju ponovne pojave napadaja nakon prvotne reakcije, drugu ili ponovnu dozu ne davati bez prethodnog liječničkog savjeta (vidjeti dio 5.2).
English: Sedation, somnolence, depressed levels of consciousness Respiratory depression
Croatian: Sedacija, somnolencija, smanjene razine svijesti Respiratorna depresija
English: Talk to your doctor or pharmacist about medicines the patient should avoid whilst taking BUCCOLAM.
Croatian: Razgovarajte s liječnikom ili ljekarnikom o lijekovima koje bolesnik treba izbjegavati za vrijeme primjene BUCCOLAMA.
English: The doctor will advise if the patient should breast-feed after being given this medicine.
Croatian: Liječnik će savjetovati treba li bolesnica dojiti nakon što primi ovaj lijek.
English: Animal studies do not indicate a teratogenic effect with respect to reproductive toxicity, but foetotoxicity has been observed in humans as with other benzodiazepines.
Croatian: Ispitivanja na životinjama ne ukazuju na teratogeni učinak s obzirom na reproduktivnu toksičnost, ali je u ljudi primijećena fetotoksičnost kao i kod drugih benzodiazepina.
English: Concomitant use with other benzodiazepines
Croatian: Istodobna primjena s drugim benzodiazepinima
English: This medicine may also stop some other medicines from working as well, e.g. levodopa (used to treat Parkinson's disease).
Croatian: Nadalje, ovaj lijek može zaustaviti djelovanje nekih lijekova, npr. levedope (lijeka koji se koristi za liječenje Parkinsonove bolesti).
English: If in any doubt, call for immediate medical help if:
Croatian: Imate li bilo kakvih dvojbi, odmah potražite liječničku pomoć ako:
English: Midazolam decreases the minimum alveolar concentration (MAC) of inhalation anaesthetics.
Croatian: Midazolam smanjuje minimalnu alveolarnu koncentraciju (MAC) inhalacijskih anestetika.
English: Metabolism of midazolam and other benzodiazepines is accelerated by xanthines.
Croatian: Metabolizam midazolama i drugih benzodiazepina ubrzan je ksantinima.
English: If prescribed by your doctor (for larger volumes and/or smaller patients), you can give approximately half the dose slowly into one side of the mouth, then into the other side of the child's mouth.
Croatian: Ako je tako propisao liječnik (za veće volumene i/ili manje bolesnike), možete polako dati otprilike polovicu doze u jednu stranu usta, a zatim drugu polovicu u drugu stranu djetetovih usta.
English: The different doses each have a different colour, which is shown on the carton, the tube and the syringe containing the medicine.
Croatian: Svaka je doza različite boje što je vidljivo na kutiji, tubi i štrcaljki s lijekom.
English: Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive, ride a bicycle or use machines.
Croatian: Sedacija, amnezija, smanjena pažnja i oštećena mišićna funkcija mogu negativno utjecati na sposobnost upravljanja vozilima, vožnje bicikla ili rukovanja strojevima.
English: The major fraction of plasma protein binding is due to albumin.
Croatian: Za većinu udjela vezanja na proteine plazme odgovoran je albumin.
English: Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded.
Croatian: S obzirom na viši omjer metabolita i osnovnog lijeka u mlađe djece, ne može se isključiti odgođena respiratorna depresija kao rezultat visokih koncentracija aktivnog metabolita u dobnoj skupini od 3 do 6 mjeseci.
English: What BUCCOLAM is and what it is used for What you need to know before you give BUCCOLAM How to give BUCCOLAM
Croatian: Što je BUCCOLAM i za što se koristi Što morate znati prije nego počnete davati BUCCOLAM
English: Small quantities of midazolam are found in human milk.
Croatian: Male količine midazolama nađene su u majčinom mlijeku u ljudi.
English: Using the finger and thumb gently pinch and pull back the child's cheek.
Croatian: Prstom i palcem nježno uhvatite djetetov obraz i povucite ga.
English: The European Medicines Agency has waived the obligation to submit the results of studies with BUCCOLAM in the subset of the paediatric population < 3months old, on the grounds that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for these paediatric patients.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka BUCCOLAM u svim podskupinama pedijatrijske populacije mlađe od 3 mjeseca, uz obrazloženje da ovaj specifični lijek ne predstavlja značajnu terapijsku korist pred postojećim načinima liječenja tih pedijatrijskih bolesnika.
English: Check that the medicine is the correct dose for your child, according to their age.
Croatian: Provjerite je li doza lijeka točna s obzirom na dob Vašega djeteta.
English: Antiepileptics
Croatian: Antiepileptici
English: The pharmacological action of midazolam is characterized by short duration because of rapid metabolic transformation.
Croatian: Farmakološko djelovanje midazolama odlikuje se kratkim trajanjem zbog brze metaboličke transformacije.
English: Midazolam belongs to a group of medicines known as benzodiazepines.
Croatian: Midazolam pripada skupini lijekova poznatih kao benzodiazepini.
English: Label colour
Croatian: Boja naljepnice
English: The fraction of the dose extracted by the liver has been estimated to be 30-60%.
Croatian: Udio doze koji se izlučuje putem jetre procijenjen je na 30 do 60%.
English: The bioavailability of oromucosal midazolam has been estimated at 87% in children with severe malaria and convulsions.
Croatian: Bioraspoloživost midazolama primijenjenog kroz oralnu sluznicu procijenjena je na 87% u djece s teškom malarijom i konvulzijama.
English: A second dose at 10 minutes results in a significant increase in mean Cmax of between 1.7 to 1.9 fold.
Croatian: Druga doza nakon 10 minuta uzrokuje značajan porast srednje vrijednosti Cmax između 1,7 do 1,9 puta.
English: Animal studies did not show an impairment of fertility (see section 5.3).
Croatian: Plodnost Ispitivanja na životinjama nisu pokazala oštećenje plodnosti (vidjeti dio 5.3).
English: Buccolam must not be injected.
Croatian: BUCCOLAM ne smije biti ubrizgan injekcijom.
English: If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.
Croatian: Ne prestane li napadaj unutar 10 minuta nakon primjene midazolama, mora se pozvati hitna medicinska pomoć te pokazati zdravstvenim djelatnicima prazne štrcaljke radi informacije o dozama koje je primio bolesnik.
English: • rifampicin (used to treat tuberculosis)
Croatian: • rifampicin (koristi se za liječenje tuberkuloze) i
English: Alcohol (including alcohol-containing medicinal products may markedly enhance the sedative effect of midazolam.
Croatian: Alkohol (uključujući lijekove koji sadrže alkohol) može znatno povećati sedacijski učinak midazolama.
English: Each oral syringe is individually packed in a protective plastic tube.
Croatian: Svaka štrcaljka za usta zasebno je pakirana u zaštitnoj plastičnoj tubi.
English: One episode of pruritus was possibly attributed to the use of buccal midazolam.
Croatian: Jedna epizoda pruritusa vjerojatno se mogla pripisati bukalnoj uporabi midazolama.
English: After receiving this medicine, the patient should not drive a vehicle, ride a bicycle or operate a machine until they have completely recovered.
Croatian: Nakon što primi ovaj lijek, bolesnik ne smije upravljati vozilom, voziti bicikl niti upravljati strojevima sve dok se potpuno ne oporavi.
English: Slowly press the syringe plunger until the plunger stops.
Croatian: Polako gurajte klip štrcaljke dok se ne zaustavi.
English: In a population pharmacokinetic study, the metabolite levels are shown to be higher in younger than older paediatric patients and thus likely to be of more importance in children than in adults.
Croatian: U farmakokinetičkom ispitivanju provedenom na populaciji, pokazalo se da su razine metabolita više u mlađih nego u starijih pedijatrijskih bolesnika, pa stoga imaju veće značenje u djece u odnosu na odrasle bolesnike.
English: Midazolam may cause inhibition of levodopa.
Croatian: Midazolam može uzrokovati inhibiciju levodope.
English: Midazolam has a major influence on the ability to drive and use machines.
Croatian: Midazolam značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables midazolam to form the hydrochloride salt with acids.
Croatian: Bazični dušik u položaju 2 u imidazobenzodiazepinskom prstenu omogućava midazolamu formiranje hidrokloridne soli s kiselinama.
English: Calcium-channel blockers
Croatian: Blokatori kalcijevih kanala
English: • Agitation, restlessness, hostility, rage or aggression, excitement, confusion, euphoria (an excessive feeling of happiness or excitement), or hallucinations (seeing and possibly hearing things that are not really there)
Croatian: • uznemirenost, nemir, neprijateljsko raspoloženje, bijes ili agresija, uzbuđenje, smetenost, euforija (osjećaj pretjerane sreće ili uzbuđenja) ili halucinacije (osoba vidi i možda čuje nešto čega zapravo nema)
English: Carers should only administer a single dose of midazolam.
Croatian: Njegovatelji smiju primijeniti samo jednu dozu midazolama.
English: After receiving midazolam, the patient should be warned not to drive a vehicle or operate a machine until completely recovered.
Croatian: Nakon primanja midazolama, bolesnika treba upozoriti da ne vozi ili da ne upravlja strojevima dok se potpuno ne oporavi.
English: This medicine may cause people to forget what happened after they have been given it.
Croatian: Ovaj lijek može također prouzročiti da se bolesnik ne sjeća što se događalo nakon njegove primjene.
English: • A lung condition that causes difficulty breathing on a regular basis.
Croatian: • bolest pluća koja redovito uzrokuje otežano disanje.
English: The elimination half-life of midazolam is prolonged up to six times in the critically ill.
Croatian: Poluvijek eliminacije midazolama produljen je do šest puta u kritičnih bolesnika.
English: Signs may include chest pain which may spread to the child's neck and shoulders and down their left arm.
Croatian: Znakovi mogu uključivati bol u prsima koji se može širiti u vrat i ramena te niz djetetovu lijevu ruku.
English: Common: ≥ 1/100 to < 1/10
Croatian: ≥ 1/100 i < 1/10
English: These produce a stable solution suitable for oromucosal administration.
Croatian: Time se dobiva stabilna otopina, prikladna za primjenu kroz oralnu sluznicu.
English: > 6 months to < 1 year
Croatian: > 6 mjeseci do < 1 godine
English: • 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
Croatian: • opazite znakove srčanog udara koji mogu uključivati bol u prsima ili bol koji se širi prema vratu i ramenima te niz lijevu ruku
English: As a result it may not be necessary to stop breast feeding following a single dose of midazolam.
Croatian: Posljedično tome, možda nije potrebno prestati dojiti nakon pojedinačne doze midazolama.
English: Midazolam is excreted mainly by the renal route (60-80% of the injected dose) and recovered as glucuroconjugated alphahydroxy-midazolam.
Croatian: Midazolam se izlučuje uglavnom putem bubrega (60 do 80% injicirane doze) u obliku glukurokonjugiranog alfa-hidroksi-midazolama.
English: Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Croatian: Posebna pozornost u intenzivnoj skrbi treba biti usmjerena na respiratorne i kardiovaskularne funkcije.
English: • Laryngospasm (tightening of the vocal cords causing difficult and noisy breathing)
Croatian: • laringospazam (glasnice se stisnu i prouzroče otežano i šumno disanje)
English: If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption.
Croatian: Ako se pražnjenjem želuca ne postigne poboljšanje, potrebno je smanjiti apsorpciju primjenom aktivnog ugljena.
English: Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.
Croatian: Vrh štrcaljke umetnite u stražnji dio prostora između unutrašnje strane obraza i donjih desni.
English: Preparing to give this medicine
Croatian: Priprema za davanje lijeka
English: Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution.
Croatian: Treba izbjegavati uštrcavanje u laringotrahealni prostor kako bi se spriječila nehotična aspiracija otopine.
English: Anaesthetics and narcotic analgesics
Croatian: Anestetici i opioidni analgetici
English: The effects of BUCCOLAM may be reduced by medicines such as:
Croatian: Učinci BUCCOLAMA mogu biti smanjeni primjenom lijekova kao što su:
English: Seek medical advice immediately or telephone for an ambulance if the patient experiences the following:
Croatian: Odmah potražite savjet liječnika ili pozovite hitnu medicinsku pomoć ako u bolesnika opazite sljedeće:
English: The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).
Croatian: Drugi sastojci su natrijev klorid, voda za injekciju, kloridna kiselina i natrijev hidroksid (za podešavanje pH).
English: Medicinal products that induce CYP3A4
Croatian: Lijekovi koji induciraju CYP3A4
English: Tel: +44(0)1256 894 959
Croatian: Tel: +44(0)1256 894 959 E-mail: medinfoEMEA@shire.com
English: The free base is a lipophilic substance with low solubility in water.
Croatian: Slobodna je baza lipofilna tvar, slabo topljiva u vodi.
English: Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube.
Croatian: Uzmite plastičnu tubu, otkinite nepropusni zatvarač s jedne strane i povucite kapicu.
English: Midazolam may cause anterograde amnesia.
Croatian: Midazolam može uzrokovati anterogradnu amneziju.
English: BUCCOLAM may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness).
Croatian: BUCCOLAM može povećati učinak nekih mišićnih relaksansa (lijekova za opuštanje mišića), npr. baklofena (uzrokuje veću pospanost).
English: BUCCOLAM is available in cartons containing 4 pre-filled oral syringes/tubes (of the same dose).
Croatian: BUCCOLAM je dostupan u kutijama koje sadrže 4 napunjene štrcaljke za usta/tube (iste doze).