FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: Pruritus, rash and urticarial
Croatian: Pruritus, osip i urtikarija
English: Cardiac insufficiency
Croatian: Srčana insuficijencija
English: Examples include opiate derivatives (used as analgesics, antitussives or substitutive treatments), antipsychotics, other benzodiazepines used as anxiolytics or hypnotics, barbiturates, propofol, ketamine, etomidate; sedative antidepressants, non-recent H1-antihistamines and centrally acting antihypertensive medicinal products.
Croatian: Primjeri uključuju opioidne derivate (koji se koriste kao analgetici, antitusici ili supstitucijska terapija), antipsihotike, druge benzodiazepine koji se koriste kao anksiolitici ili hipnotici, barbiturate,
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane prema opadajućoj ozbiljnosti: Klasifikacija organskih sustava
English: In a rat fertility study, animals dosed up to ten times the clinical dose, no adverse effects on fertility were observed.
Croatian: U ispitivanju plodnosti u štakora, štetni učinci na plodnost nisu opaženi pri dozama do deset puta većim od kliničke doze.
English: Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function.
Croatian: Midazolam treba oprezno upotrebljavati u bolesnika s kroničnim zatajenjem bubrega, oštećenom funkcijom jetre ili srca.
English: The steady state volume of distribution following oromucosal administration is estimated to be 5.3 l/kg.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže nakon primjene kroz sluznicu usta procjenjuje se na 5,3 l/kg.
English: BUCCOLAM 5 mg, 7.5 mg, 10 mg oromucosal solution 2 years
Croatian: BUCCOLAM 5 mg, 7,5 mg, 10 mg otopina za usnu sluznicu 2 godine.
English: 3 to 6 months hospital setting
Croatian: Boja naljepnice od 3 do 6 mjeseci u bolničkom okruženju
English: Precautions to be taken before handling or administering the medicinal product No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.
Croatian: Na štrcaljku za usta ne smije se pričvrstiti igla, intravenska cjevčica niti bilo koja druga naprava za parenteralnu primjenu.
English: Fluconazole and itraconazole both increased the plasma concentrations of intravenous midazolam by 2 to 3-fold associated with an increase in terminal half-life by 2.4-fold for itraconazole and 1.5-fold for fluconazole.
Croatian: Flukonazol i itrakonazol povećavaju plazmatske koncentracije intravenskog midazolama 2 do 3 puta uz povećanje terminalnog poluvijeka 2,4 puta za itrakonazol i 1,5 puta za flukonazol.
English: The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered to children in clinical studies.
Croatian: Tablica koja slijedi navodi nuspojave koje su opisane prilikom primjene midazolama preko oralne sluznice, davanog djeci u sklopu kliničkih ispitivanja.
English: No dose adjustment is required, however, BUCCOLAM should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged.
Croatian: Nije potrebno prilagođavati dozu, ali BUCCOLAM treba oprezno primjenjivati u bolesnika s kroničnim oštećenjem bubrežne funkcije jer eliminacija midazolama može biti usporena a učinci produljeni (vidjeti dio 4.4).
English: If you have any further questions on the use of this medicine, ask a doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: After oromucosal administration midazolam is absorbed rapidly.
Croatian: Apsorpcija Nakon primjene kroz oralnu sluznicu midazolam se brzo apsorbira.
English: Published clinical studies show that oromucosal midazolam was administered to approx 443 children with seizures.
Croatian: U objavljenim kliničkim ispitivanjima opisana je oromukozalna primjena midazolama u približno 443
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):
English: Atorvastatin showed a 1.4-fold increase in plasma concentrations of intravenous midazolam compared to control group.
Croatian: Atorvastatin je pokazao povećanje plazmatskih koncentracija intravenskog midazolama od 1,4 puta u usporedbi s kontrolnom skupinom.
English: Various medicinal products
Croatian: Različiti lijekovi
English: The full amount of solution should be inserted slowly into the space between the gum and the cheek (buccal cavity).
Croatian: Svu količinu otopine treba polako istisnuti u prostor između desni i obraza (bukalna šupljina).
English: Patients should be observed carefully after being given the medicine.
Croatian: Poslije primjene ovoga lijeka bolesnike treba pomno pratiti.
English: Remove the oral syringe cap before use to avoid risk of choking.
Croatian: Uklonite zatvarač štrcaljke za usta prije uporabe da biste izbjegli rizik od gušenja.
English: Azole antifungals
Croatian: Azolni antifungalni lijekovi
English: Upon co-administration with ritonavirboosted lopinavir, the plasma concentrations of intravenous midazolam increased by 5.4-fold, associated with a similar increase in terminal half-life.
Croatian: Nakon istodobne primjene s ritonavirom potpomognutim lopinavirom, plazmatske koncentracije intravenskog midazolama povećale su se 5,4 puta, što je povezano sa sličnim povećanjem terminalnog poluvijeka.
English: Tell the doctor if the patient is breast-feeding.
Croatian: Obavijestite liječnika ako bolesnica doji.
English: How long this lasts depends on how much BUCCOLAM was given..
Croatian: • privremeni gubitak pamćenja; koliko dugo će to trajati ovisi o tome koliko je BUCCOLAMA
English: Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.
Croatian: Respiratorna insuficijencija Midazolam treba oprezno upotrebljavati u bolesnika s kroničnom respiratornom insuficijencijom jer može dodatno deprimirati disanje.
English: BUCCOLAM 2.5 mg oromucosal solution BUCCOLAM 5 mg oromucosal solution BUCCOLAM 7.5 mg oromucosal solution BUCCOLAM 10 mg oromucosal solution
Croatian: BUCCOLAM 2,5 mg otopina za usnu sluznicu BUCCOLAM 5 mg otopina za usnu sluznicu BUCCOLAM 7,5 mg otopina za usnu sluznicu BUCCOLAM 10 mg otopina za usnu sluznicu
English: 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging The dose is the full contents of one oral syringe.
Croatian: Od 3 mjeseca do manje od 1 godine: 2,5 mg - pakiranje označeno žutom bojom Od 1 godine do manje od 5 godina: 5 mg - pakiranje označeno plavom bojom.
English: St John's Wort decreased plasma concentrations of midazolam by about 20-40% associated with a decrease in terminal half life of about 15-17%.
Croatian: Gospina trava smanjila je plazmatsku koncentraciju midazolama za otprilike 20-40% uz smanjenje terminalnog poluvijeka za otprilike 15-17%.
English: Voriconazole increased the exposure of intravenous midazolam by 3-fold whereas its elimination halflife increased by about 3-fold.
Croatian: Vorikonazol je povećao izloženost intravenskom midazolamu 3 puta, a poluvijek eliminacije povećan je otprilike 3 puta.
English: The oral syringe cap should be removed before use to avoid risk of choking.
Croatian: Zatvarač štrcaljke za usta treba prije uporabe ukloniti kako bi se izbjegla opasnost od gušenja.
English: BUCCOLAM oromucosal solution is a clear colourless liquid.
Croatian: BUCCOLAM otopina za usnu sluznicu, bistra je i bezbojna tekućina.
English: For children aged 3 months to less than 1 year
Croatian: Za djecu u dobi od 3 mjeseca do manje od 1 godine
English: The patient must not drink alcohol while taking BUCCOLAM.
Croatian: Dok uzima BUCCOLAM, bolesnik ne smije piti alkoholna pića.
English: There is a slow and insignificant passage of midazolam into the cerebrospinal fluid.
Croatian: Prolazak midazolama u cerebrospinalnu tekućinu spor je i beznačajan.
English: BUCCOLAM contains a medicine called midazolam.
Croatian: Što je BUCCOLAM i za što se koristi BUCCOLAM sadrži lijek zvan midazolam.
English: When to call an ambulance ALWAYS follow the treatment advice provided by the patient's doctor or as explained by a healthcare professional.
Croatian: UVIJEK se pridržavajte savjeta koje Vam je dao bolesnikov liječnik ili uputa zdravstvenog djelatnika.
English: Cimetidine, ranitidine and omeprazole have been shown to reduce the clearance of midazolam and other benzodiazepines and may potentiate their actions.
Croatian: Dokazano je da cimetidin, ranitidin i omeprazol smanjuju klirens midazolama i drugih benzodiazepina te mogu pojačati njihova djelovanja.
English: • xanthines (used to treat asthma)
Croatian: • ksantini (za liječenje astme)
English: Nabilone
Croatian: Nabilon
English: Ketoconazole increased the plasma concentrations of intravenous midazolam by 5-fold while the terminal half-life increased by about 3-fold.
Croatian: Ketokonazol je povećao plazmatske koncentracije intravenskog midazolama 5 puta, dok je terminalni poluvijek povećan oko 3 puta.
English: In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Croatian: U blagim slučajevima simptomi uključuju omamljenost, mentalnu konfuziju i letargiju, u ozbiljnijim slučajevima simptomi mogu uključivati ataksiju,
English: Bradycardia**, cardiac arrest**, hypotension**, vasodilatation**
Croatian: Vrlo rijetko: Bradikardija**, srčani zastoj**, hipotenzija**, vazodilatacija**
English: Co-administration with midazolam may cause enhanced sedation or respiratory or cardiovascular depression.
Croatian: Istodobna primjena s midazolamom može uzrokovati povećanu sedaciju ili respiratornu ili kardiovaskularnu depresiju.
English: AUC0-inf (ng.h/ml) Cmax (ng/ml)
Croatian: Cmax (ng/ml)
English: Midazolam may interact with other hepatically metabolised medicinal products, e.g. phenytoin, causing potentiation.
Croatian: Midazolam može uzajamno djelovati s drugim lijekovima koji se metaboliziraju u jetri, kao što je fenitoin i pojačati njihovo djelovanje.
English: Clarithromycin increased the plasma concentrations of intravenous midazolam by up to 2.5-fold associated with an increase in terminal half-life by 1.5 to 2-fold.
Croatian: Klaritromicin je povećao plazmatske koncentracije intravenskog midazolama do 2,5 puta, što se povezuje s povećanjem terminalnog poluvijeka 1,5 do 2 puta.
English: Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.
Croatian: Zlouporaba alkohola ili droge u anamnezi Midazolam treba izbjegavati u bolesnika s anamnezom zlouporabe alkohola ili droga.
English: Fatigue**, hiccups** **These adverse reactions have been reported to occur when midazolam is injected in children and/or adults, which may be of relevance to oromucosal administration.
Croatian: ** Ove nuspojave zabilježene su u djece i/ili odraslih prilikom injiciranja midazolama, što može biti od značaja za primjenu preko oralne sluznice.
English: AUC0-inf (ng.h/ml) Cmax (ng/ml) 10 mg 10 yrs < 18 yrs AUC0-inf (ng.h/ml) Cmax (ng/ml)
Croatian: 10 mg 10 god < 18 god AUC0-inf (ng.h/ml) Cmax (ng/ml)
English: How to store BUCCOLAM Contents of the pack and other information
Croatian: Kako BUCCOLAM izgleda i sadržaj pakiranja
English: NAME OF THE MARKETING AUTHORISATION HOLDER Shire logo
Croatian: Logotip tvrtke Shire
English: For children aged 10 years to less than 18 years
Croatian: Za djecu u dobi od 10 godina do manje od 18 godina.
English: It is supplied in an amber coloured prefilled, single-use oral syringe.
Croatian: Isporučuje se u napunjenoj štrcaljki za usta boje jantara za jednokratnu uporabu.
English: Do not attach a needle to the syringe Step 1
Croatian: Ne stavljajte iglu na štrcaljku.
English: • anti-ulcer medicines, e.g. cimetidine, ranitidine and omeprazole
Croatian: • antiulkusni lijekovi (protiv vrijeda na želucu), npr. cimetidin, ranitidin i omeprazol
English: An increased risk for falls and fractures has been recorded in elderly benzodiazepine users.
Croatian: U korisnika benzodiazepina starije dobi zabilježen je povećani rizik od padova i lomova.
English: Midazolam may cause potentiation of muscle relaxants, with increased CNS depressant effects.
Croatian: Midazolam može pojačati djelovanja miorelaksansa s povećanim učincima depresije SŽS-a.
English: INFORMATION IN BRAILLE BUCCOLAM 10 mg
Croatian: BUCCOLAM 10 mg
English: For children aged 5 years to less than 10 years
Croatian: Za djecu u dobi od 5 godina do manje od 10 godina
English: Dopaminergic medicinal products
Croatian: Dopaminergički lijekovi
English: • A disease of the nerves and muscles causing muscle weakness (myasthenia gravis)
Croatian: • bolest živaca i mišića koja uzrokuje slabost mišića (miastenija gravis) • jako otežano disanje u mirovanju (BUCCOLAM može pogoršati poteškoće s disanjem)
English: • medicines used to treat nausea, e.g. nabilone
Croatian: • lijekovi protiv mučnine, npr. nabilon
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (7.5 mg/1.5 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija (7,5 mg/1,5 ml)
English: 5 years to < 10 years Purple
Croatian: 3 ml od 5 godina do < 10 godina ljubičasta
English: Pharmacodynamic Drug-Drug Interactions (DDI)
Croatian: Farmakodinamičke lijek-lijek interakcije
English: The clearance is not significantly different in obese and non-obese patients.
Croatian: Klirens se ne razlikuje značajno u gojaznih bolesnika i onih s normalnom tjelesnom težinom.
English: Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section Myasthenia gravis
Croatian: Preosjetljivost na djelatnu tvar, benzodiazepine ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:
Croatian: Prije davanja BUCCOLAMA, provjerite s liječnikom ili ljekarnikom ima li bolesnik:
English: 6.6 Special precautions for disposal and other handling Administration of BUCCOLAM
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: Xanthines
Croatian: Ksantini
English: For children aged 1 year to less than 5 years
Croatian: Za djecu u dobi od 1 godine do manje od 5 godina.
English: Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt) Sodium hydroxide (for pH adjustment)
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev klorid voda za injekcije kloridna kiselina (za podešavanje pH i konverziju midazolama u midazolamklorid) natrijev hidroksid (za podešavanje pH)
English: For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Croatian: Liječenje dojenčadi u dobi od 3 do 6 mjeseci treba provoditi u bolničkom okruženju gdje je moguće praćenje i gdje je na raspolaganju oprema za oživljavanje.
English: BUCCOLAM is for oromucosal use.
Croatian: BUCCOLAM se primjenjuje preko oralne sluznice.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (10 mg/2 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija (10 mg/2 ml)
English: What BUCCOLAM looks like and contents of the pack 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging
Croatian: Uputa o lijeku: Informacije za korisnika BUCCOLAM 2,5 mg otopina za usnu sluznicu Za djecu u dobi od 3 mjeseca do manje od 1 godine BUCCOLAM 5 mg otopina za usnu sluznicu Za djecu u dobi od 1 godine do manje od 5 godina BUCCOLAM 7,5 mg otopina za usnu sluznicu Za djecu u dobi od 5 godina do manje od 10 godina BUCCOLAM 10 mg otopina za usnu sluznicu Za djecu u dobi od 10 godina do manje od 18 godina midazolam
English: In infants from 3 months to less than 6 months it should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available.
Croatian: U dojenčadi u dobi od 3 mjeseca do manje od 6 mjeseci smije se primjenjivati samo u bolničkom okruženju gdje je moguće praćenje i gdje je na raspolaganju oprema za oživljavanje.
English: Depending on the specific St John's Wort extract, the CYP3A4-inducing effect may vary.
Croatian: Učinci induciranja CYP3A4 mogu varirati ovisno o specifičnom ekstraktu gospine trave.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (2.5 mg/0.5 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija (2,5 mg/0,5 ml)
English: Simulated pharmacokinetic parameters for the recommended posology in children aged 3 months to less than 18 years, based on a population pharmacokinetic study are provided in tabulated format below:
Croatian: godina, određeni na temelju farmakokinetičkog ispitivanja provedenog na populaciji, prikazani su u obliku tablice kako slijedi:
English: INFORMATION IN BRAILLE BUCCOLAM 5 mg
Croatian: BUCCOLAM 5 mg
English: This should be avoided in patients taking BUCCOLAM.
Croatian: Primjenu toga lijeka treba izbjegavati u bolesnika koji uzimaju
English: Toddlers aged from 3 months to less than 6 months should only be treated in a hospital setting where monitoring is possible and resuscitation equipment is available.
Croatian: Liječenje male djece u dobi od 3 mjeseca do manje od 6 mjeseci treba provoditi samo u bolničkom okruženju gdje je moguće praćenje i gdje je na raspolaganju oprema za oživljavanje.
English: INFORMATION IN BRAILLE BUCCOLAM 7.5 mg
Croatian: BUCCOLAM 7,5 mg
English: • Each 10 mg pre-filled oral syringe contains 10 mg midazolam (as hydrochloride) in 2 ml solution.
Croatian: • Svaka napunjena štrcaljka za usta od 10 mg sadrži 10 mg midazolama (u obliku midazolamklorida) u 2 ml otopine.
English: Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal halflife.
Croatian: Oštećenje jetrene funkcije Oštećenje jetrene funkcije smanjuje klirens midazolama s posljedičnim povećanjem poluvijeka.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 7.5 mg /1.5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 7,5 mg/1,5 ml
English: Ulcer-healing medicinal products
Croatian: Lijekovi za liječenje ulkusa želuca
English: • Each 7.5 mg pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution.
Croatian: • Svaka napunjena štrcaljka za usta od 7,5 mg sadrži 7,5 mg midazolama (u obliku midazolamklorida) u 1,5 ml otopine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (5 mg/1 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija (5 mg/1 ml)
English: Posaconazole increased the plasma concentrations of intravenous midazolam by about 2-fold.
Croatian: Pozakonazol je povećao plazmatske koncentracije intravenskog midazolama otprilike 2 puta.
English: There are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
Croatian: Osim pretkliničkih podataka o sigurnosti već uključenih u druge dijelove Sažetka opisa svojstava lijeka, nema drugih podataka bitnih za propisivača.
English: INFORMATION IN BRAILLE BUCCOLAM 2.5 mg
Croatian: BUCCOLAM 2,5 mg
English: Remove the oral syringe cap before use.
Croatian: Prije uporabe uklonite zatvarač štrcaljke za usta.
English: BUCCOLAM 10 mg oromucosal solution midazolam
Croatian: BUCCOLAM 10 mg otopina za usnu sluznicu midazolam
English: The frequency of adverse reactions is classified as follows:
Croatian: Učestalost nuspojava klasificirana je na sljedeći način:
English: • Each 2.5 mg pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution.
Croatian: • Svaka napunjena štrcaljka za usta od 2,5 mg sadrži 2,5 mg midazolama (u obliku midazolamklorida) u 0,5 ml otopine.
English: BUCCOLAM 10 mg oromucosal solution EU/1/11/709/004
Croatian: BUCCOLAM 10 mg otopina za usnu sluznicu EU/1/11/709/004
English: • Each 5 mg pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution.
Croatian: • Svaka napunjena štrcaljka za usta od 5 mg sadrži 5 mg midazolama (u obliku midazolamklorida) u 1 ml otopine.
English: If you have any doubt about whether any medicine the patient is taking may affect the use of BUCCOLAM, please speak to your doctor or pharmacist.
Croatian: Ako ste u nedoumici može li bilo koji lijek koji uzima bolesnik utjecati na djelovanje
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 10 mg /2 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 10 mg/2 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 7.5 mg/1.5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 7,5 mg/1,5 ml
English: Strengths 5 mg, 7.5 mg and 10 mg:
Croatian: Jačine od 5 mg, 7,5 mg i 10 mg: Lijek se izdaje na recept.
English: BUCCOLAM 7.5 mg oromucosal solution midazolam
Croatian: BUCCOLAM 7,5 mg otopina za usnu sluznicu midazolam
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 2.5 mg/0.5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 2,5 mg/0,5 ml
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 2.5 mg /0.5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 2,5 mg/0,5 ml
English: even if their signs of illness are the same as those of the child for whom this medicine has been prescribed.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki onima u djeteta kojemu je ovaj lijek propisan.
English: Nausea and vomiting Very rare:
Croatian: Poremećaji probavnog sustava Često: Mučnina i povraćanje
English: 4 pre-filled oral syringes
Croatian: Otopina za usnu sluznicu 4 napunjene štrcaljke za usta
English: BUCCOLAM 7.5 mg oromucosal solution EU/1/11/709/003
Croatian: BUCCOLAM 7,5 mg otopina za usnu sluznicu EU/1/11/709/003
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 10 mg/2 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 10 mg/2 ml
English: BUCCOLAM 5 mg oromucosal solution EU/1/11/709/002
Croatian: BUCCOLAM 5 mg otopina za usnu sluznicu EU/1/11/709/002
English: BUCCOLAM 2.5 mg oromucosal solution For children aged 3 months to less than 1 year
Croatian: BUCCOLAM 2,5 mg otopina za usnu sluznicu 18 mjeseci
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 5 mg /1 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Naljepnica na plastičnoj tubi 5 mg/1 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 5 mg/1 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Plastična štrcaljka za usta 5 mg/1 ml
English: 2 ml
Croatian: 10 mg 2 ml
English: 5 years to < 10 years
Croatian: 5 mg plava od 5 godina do < 10 godina
English: 1.5 ml
Croatian: 5 mg 1 ml
English: For children aged 5 years to less than 10 years For oromucosal use only
Croatian: Za djecu u dobi od 1 godine do manje od 5 godina Samo za usnu sluznicu.
English: BUCCOLAM 2.5 mg oromucosal solution midazolam
Croatian: BUCCOLAM 2,5 mg otopina za usnu sluznicu midazolam
English: • St John's Wort (a herbal medicine).
Croatian: • gospina trava (biljni lijek).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (2 ml) contains 10 mg midazolam (as hydrochloride)
Croatian: Svaka napunjena štrcaljka za usta (2 ml) sadrži 10 mg midazolama (u obliku midazolamklorida).
English: Purple
Croatian: BUCCOLAM.