natgillin/translations-raw huggingface dataset:
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.
Če ste negotovi, ali lahko katero od zdravil, ki ga jemlje bolnik, vpliva na uporabo zdravila BUCCOLAM, se pogovorite s svojim zdravnikom ali s farmacevtom.
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
Izgled zdravila BUCCOLAM in vsebina pakiranja 3 mesece do manj kot 1 leto: 2,5 mg - rumeno označeno pakiranje, 1 leto do manj kot 5 let: 5 mg - modro označeno pakiranje, 5 let do manj kot 10 let: 7,5 mg - vijolično označeno pakiranje, 10 let do manj kot 18 let: 10 mg - oranžno označeno pakiranje.
The elimination half-life of midazolam is prolonged up to six times in the critically ill.
Razpolovna doba izločanja midazolama se pri kritično bolnih podaljša za do šestkrat.
There are no or limited amount of data from the use of midazolam in pregnant women.
Podatkov o uporabi midazolama pri nosečnicah ni oziroma so omejeni.
4.5 Interaction with other medicinal products and other forms of interaction Midazolam is metabolized by CYP3A4.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Midazolam presnavlja CYP3A4.
Other medicines and BUCCOLAM
Druga zdravila in zdravilo BUCCOLAM
Alcohol may increase the sedative effects of this medicine and make them very sleepy.
Alkohol lahko okrepi sedativne učinke tega zdravila in bolnika naredi zelo zaspanega.
After receiving midazolam, the patient should be warned not to drive a vehicle or operate a machine until completely recovered.
Bolnika je treba po prejemu midazolama opozoriti, da naj ne vozi in ne upravlja s stroji, dokler povsem ne okreva.
• Muscle spasms and muscle tremors (shaking of your muscles that you cannot control)
• mišični spazmi in mišični tremor (trzanje mišic, ki ga ne bolnik more nadzirati);
10 years to < 18 years Orange
10 let do < 18 let oranžna
Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution.
Preprečite laringotrahealno vstavitev, da ne pride do nezgodne aspiracije raztopine.
The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).
Druge sestavine zdravila so natrijev klorid, voda za injekcije, klorovodikova kislina in natrijev hidroksid (za uravnavanje pH).
These produce a stable solution suitable for oromucosal administration.
Tako nastane stabilna raztopina, primerna za oralno apliciranje.
The free base is a lipophilic substance with low solubility in water.
Prosta baza je lipofilna snov z nizko vodotopnostjo.
• A lung condition that causes difficulty breathing on a regular basis.
• bolezen pljuč, ki povzroča stalno oteženo dihanje.
BUCCOLAM is contraindicated in patients with severe hepatic impairment (see section 4.3).
Zdravilo BUCCOLAM je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
Do not give BUCCOLAM if the patient has:
Bolniku ne dajajte zdravila BUCCOLAM, če ima:
BUCCOLAM is available in cartons containing 4 pre-filled syringes.
Zdravilo BUCCOLAM je na voljo v škatlah, ki vsebujejo 4 napolnjene brizge.
Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube.
Primite plastični ovitek, prelomite pečat na enem koncu in odstranite pokrovček.
Do not give more than the amount of medicine prescribed by a doctor for the patient.
Bolniku ne dajte večjega odmerka, kot mu ga je predpisal zdravnik.
How to store BUCCOLAM Contents of the pack and other information
Shranjevanje zdravila BUCCOLAM Vsebina pakiranja in dodatne informacije
Following oromucosal administration in children the area under the curve ratio for alpha-hydroxy midazolam to midazolam is 0.46.
Po oralnem dajanju otrokom je razmerje površine pod krivuljo med alfa-hidroksi-midazolamom in midazolamom 0,46.
Midazolam is excreted in low quantities (0.6%) in human milk.
Midazolam se v majhnih količinah (0,6 %) izloča v materino mleko.
It also exerts a sedative and sleepinducing effect of pronounced intensity, and an anxiolytic and a muscle-relaxant effect.
Deluje tudi močno sedativno in uspavalno, kakor tudi anksiolitično in kot mišični relaksant.
• You're unable to empty the syringe or you spill some of the contents
o ne morete izprazniti brizge ali se vam razlije del vsebine;
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).
Poročajo, da je dajanje visokih odmerkov midazolama v zadnjem trimesečju nosečnosti ali med porodom povzročilo neželene dogodke za mater ali plod (tveganje aspiracije tekočine in vsebine želodca med porodom pri materi, nepravilnosti srčnega utripa pri plodu, hipotonijo, slabo sesanje, hipotermijo in respiratorno depresijo pri novorojencih).
BUCCOLAM may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness).
Zdravilo BUCCOLAM lahko zveča učinek nekaterih mišičnih relaksantov, npr. baklofena (ki zvečuje zaspanost).
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.
Zelo redki: utrujenost**, kolcanje** **Poročali so, da se ti neželeni učinki pojavljajo ob injiciranju midazolama otrokom in/ali odraslim, kar je morda pomembno za oralno dajanje.
• Heart attack.
• srčni infarkt.
PHARMACEUTICAL FORM AND CONTENTS Oromucosal solution
FARMACEVTSKA OBLIKA IN VSEBINA oralna raztopina
• antibiotics, e.g. erythromycin, clarithromycin
• antibiotiki, npr. eritromicin, klaritromicin,
Keep the syringe to show to the ambulance staff or doctor.
Brizgo vzemite s seboj in jo pokažite reševalcem ali zdravniku.
Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive, ride a bicycle or use machines.
Sedacija, amnezija, poslabšanje pozornosti in poslabšanje mišičnega delovanja lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
In a rat fertility study, animals dosed up to ten times the clinical dose, no adverse effects on fertility were observed.
V študiji vpliva na sposobnost razmnoževanja pri podganah, v katerih so živalim dajali do desetkrat večje odmerke od kliničnih, niso opazili neželenih vplivov na sposobnost razmnoževanja.
Talk to your doctor or pharmacist before giving BUCCOLAM if the patient has:
Posvetujte se z zdravnikom ali s farmacevtom, preden date zdravilo BUCCOLAM bolniku, če ima bolnik:
The patient must not drink alcohol while taking BUCCOLAM.
Bolnik ne sme piti alkohola, medtem ko uporablja zdravilo BUCCOLAM.
3 months to < 1 year Yellow
3 mesece do < 1 leto rumena
Seek medical advice immediately or telephone for an ambulance if the patient experiences the following:
Takoj poiščite medicinsko pomoč ali pokličite reševalce, če se bolniku zgodi kaj od naslednjega:
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.
Pogostnost in resnost neželenih učinkov, o katerih so poročali za oralno apliciran midazolam, sta bili podobni neželenim učinkom, o katerih so poročali v primerjalni skupini, v kateri so bolnikom rektalno aplicirali diazepam.
What you need to know before you give BUCCOLAM
Kaj morate vedeti, preden boste uporabili zdravilo BUCCOLAM
Plasma clearance of midazolam in children following oromucosal administration is 30 ml/kg/min.
Očistek midazolama v plazmi pri otrocih po oralnem dajanju je 30 ml/kg/min.
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:
5.2 Farmakokinetične lastnosti Simulirani farmakokinetični parametri za priporočeno dajanje otrokom starim od 3 mesece do manj kot 18 let na podlagi farmakokinetičnih študij populacije so navedeni spodaj v obliki preglednice: Odmerek
The patient must not drink grapefruit juice while taking BUCCOLAM.
Bolnik ne sme piti grenivkinega soka, medtem ko uporablja zdravilo BUCCOLAM.
The table below lists the adverse reactions reported to occur when oromucosal midazolam was administered to children in clinical studies.
V spodnji preglednici so našteti neželeni učinki, o katerih so poročali po oralnem dajanju midazolama otrokom v kliničnih študijah.
Midazolam has an anticonvulsant effect.
Midazolam deluje antikonvulzivno.
Midazolam is hydroxylated by the cytochrome P4503A4 isozyme and the major urinary and plasma metabolite is alpha-hydroxy-midazolam.
Midazolam hidroksilira izocim citokroma P4503A4; glavni presnovek v urinu in plazmi je alfa-hidroksi-midazolam.
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.
Poiskati mora nujno medicinsko pomoč, če epileptični napad ne mine v 10 minutah po dajanju midazolama, ter zdravstvenemu delavcu izročiti prazno brizgo kot informacijo o odmerku, ki ga je bolnik prejel.
BUCCOLAM contains a medicine called midazolam.
Zdravilo BUCCOLAM vsebuje zdravilno učinkovino, imenovano midazolam.
Midazolam is a derivative of the imidazobenzodiazepine group.
Midazolam je derivat skupine imidazobenzodiazepinov.
• The child is sick (vomits) and the seizure does not stop within 10 minutes
o je otroku slabo (bruha) in epileptični napad v 10 minutah ne mine;
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.
Dodatno so v 2 od teh študij opazili, da so pri 56 % do 70 % otrok prenehali vidni znaki epileptičnih napadov v 10 minutah in da se v roku 1 ure po aplikaciji niso ponovili.
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.
Zaviralci in induktorji encima CYP3A4 lahko bodisi povišajo ali znižajo koncentracijo v plazmi in posledično učinke midazolama, zato je treba odmerek ustrezno prilagoditi.
> 6 months to < 1 year
> 6 mesecev do < 1 leto
Medicinal products that induce CYP3A4
Zdravila, ki inducirajo encim CYP3A4
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.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
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.
Zato je treba uporabo zdravila BUCCOLAM v skupini 3-6 mesecev omejiti na uporabo pod nadzorom zdravstvenega delavca v okolju kjer je na voljo oprema za oživljanje, kjer je mogoče dihalne funkcije spremljati in je po potrebi na voljo oprema za podporo pri dihanju.
BUCCOLAM oromucosal solution is a clear colourless liquid.
Zdravilo BUCCOLAM oralna raztopina je bistra, brezbarvna tekočina.
After a single dose of oromucosal midazolam, the consequence on the maximal clinical effect due to CYP3A4 inhibition will be minor while the duration of effect may be prolonged.
Po enkratnem odmerku oralnega midazolama je vpliv zaviranja CYP3A4 na največji klinični učinek midazolama manjši, medtem ko se lahko trajanje učinka podaljša.
This should be avoided in patients taking BUCCOLAM.
Pri bolnikih, ki jemljejo zdravilo BUCCOLAM, se ji je treba izogibati.
Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.
Napolnjene brizge (polipropilen) brez igle za peroralno dajanje z batom (polipropilen) in pokrovčkom (polietilen visoke gostote) jantarne barve, pakirane v zaščitnem plastičnem ovitku s pokrovom.
After oromucosal administration midazolam is absorbed rapidly.
Po oralnem dajanju se midazolam hitro absorbira.
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).
Zdravilo BUCCOLAM uporabljamo za zaustavitev nenadnih, dolgotrajnih, konvulzivnih napadov pri dojenčkih, malčkih, otrocih in mladoletnikih (starih od 3 mesece do 18 let).
How to give BUCCOLAM
Kako dati zdravilo BUCCOLAM
• Severe breathing difficulties e.g. slow or shallow breathing or blue lips.
• izrazite težave z dihanjem, npr. počasno ali plitko dihanje ali modre ustnice.
6.6 Special precautions for disposal and other handling Administration of BUCCOLAM
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Uporaba zdravila BUCCOLAM
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).
Ker so lahko klinični učinki močnejši in podaljšani, se po dajanju midazolama bolnikom z okvaro jeter priporoča skrbno nadziranje kliničnih učinkov in življenjskih znakov (glejte poglavje 4.4).
This medicine should be avoided in patients with a medical history of alcohol or drug abuse.
Izogibajte se temu zdravilu pri bolnikih z anamnezo zlorabe alkohola ali mamil.
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.
Farmakokinetične interakcije z zaviralci ali induktorji encima CYP3A4 so bolj izrazite pri peroralnem dajanju midazolama, kakor pa pri oralnem ali parenteralnem, saj so encimi CYP3A4 lahko prisotni v zgornjih prebavilih.
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.
Učinki zaviralcev CYP3A4 so lahko pri dojenčkih večji, saj verjetno del oralnega odmerka pogoltnejo in se absorbira v prebavilih.
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.
Po 30 in 60 minutah je že prišlo do precejšnjega izločanja midazolama, zato je povečanje povprečnega Cmax manj izrazito: 1,3- do
The pharmacological action of midazolam is characterized by short duration because of rapid metabolic transformation.
Farmakološko delovanje midazolama je kratkotrajno, ker se midazolam hitro presnavlja.
For oromucosal use only.
Samo za oralno uporabo.
7 days of 600 mg once daily decreased the plasma concentrations of intravenous midazolam by about 60%.
Rifampicin 7 dni po 600 mg enkrat na dan je po intravenskem dajanju midazolama zmanjšal njegovo koncentracijo v plazmi za približno 60 %.
Anterograde amnesia**, ataxia**, dizziness**, headache**, seizure**, paradoxical reactions**
anterogradna amnezija**, ataksija**, omotičnost**, glavobol**, epileptični napad**, paradoksalne reakcije**
Uncommon: ≥ 1/1,000 to < 1/100
≥ 1/1.000 do < 1/100 Zelo redki: < 1/10.000
BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.
Zdravilo BUCCOLAM lahko uporabljajo samo starši/negovalci pri bolnikih, ki imajo diagnozo epilepsije.
Midazolam belongs to a group of medicines known as benzodiazepines.
Midazolam sodi v skupino zdravil, imenovanih benzodiazepini.
• sedative antidepressants (medicines used to treat depression that make you sleepy)
• sedativni antidepresivi (zdravila, ki se uporabljajo za zdravljenje depresije in povzročajo zaspanost), • sedativi (pomirjevala),
If you are not sure if any of the above applies to the patient, talk to a doctor or pharmacist before giving this medicine.
Če niste prepričani, ali karkoli od zgoraj navedenega velja za bolnika, se pogovorite z zdravnikom ali s farmacevtom, preden bolniku date zdravilo BUCCOLAM.
Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.
Vtaknite konico brizge v zadnji del prostora med notranjostjo lica in dlesnijo spodnje čeljusti.
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).
Življenjsko nevarni dogodki so bolj verjetni pri bolnikih z obstoječo respiratorno insuficienco ali okvarjenim delovanjem srca, zlasti pri odmerjanju velikih odmerkov (glejte poglavje 4.4).
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.
Če je tako predpisal zdravnik (pri večjih količinah in/ali manjših bolnikih), lahko date približno pol odmerka počasi v eno stran ust,
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).
Razpolovna doba pri bolnikih s cirozo jeter je lahko v primerjavi z zdravimi prostovoljci daljša in očistek manjši (glejte poglavje 4.4).
BUCCOLAM may make the patient sleepy, forgetful or affect their concentration and co-ordination.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo BUCCOLAM lahko naredi bolnika zaspanega, pozabljivega ali vpliva na njegovo koncentracijo ali koordinacijo.
4 pre-filled oral syringes
4 napolnjene brizge za peroralno dajanje
If you have any further questions on the use of this medicine, ask a doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
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.
Farmakodinamične interakcije med zdravili Sočasno dajanje midazolama z drugimi sedativnimi/hipnotičnimi zdravili in zaviralci osrednjega živčevja, vključno z alkoholom, bo verjetno okrepilo sedacijo in respiratorno depresijo.
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.
Prilagajanje odmerka ni potrebno, vendar pa je treba zdravilo BUCCOLAM uporabljati previdno pri bolnikih s kronično ledvično odpovedjo, ker se lahko izločanje midazolama zakasni, učinki pa podaljšajo (glejte poglavje 4.4).
• A kidney, liver or heart condition
• bolezen ledvic, jeter ali srca,
Dopaminergic medicinal products
Dopaminergična zdravila
The mean half-life is greater in obese than in non-obese patients (5.9 versus 2.3 hours).
Srednja razpolovna doba je pri bolnikih s prekomerno telesno maso daljša kot pri bolnikih z normalno telesno maso (5,9 ur v primerjavi z 2,3 urama).
Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
Midazolam se lahko pri bolnikih s kronično ledvično odpovedjo ali okvarjenem delovanju jeter kopiči, medtem ko lahko pri bolnikih z okvarjenim delovanjem srca povzroči zmanjšanje očistka midazolama.
BUCCOLAM is available in cartons containing 4 pre-filled oral syringes/tubes (of the same dose).
Zdravilo BUCCOLAM je na voljo v pakiranjih s po 4 napolnjenimi brizgami za peroralno dajanje/plastičnimi ovitki (z enakimi odmerki).
The steady state volume of distribution following oromucosal administration is estimated to be 5.3 l/kg.
Ocenjeno je, da je volumen porazdelitve v stanju dinamičnega ravnovesja po oralnem dajanju 5,3 l/kg.
Buccolam must not be injected.
Zdravila BUCCOLAM ne smemo injicirati.
Very rare side effects (may affect up to 1 in 10,000 people):
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
10 years to < 18 years
10 let do < 18 let
The doctor will advise if the patient should breast-feed after being given this medicine.
Zdravnik vam bo svetoval, ali naj po uporabi tega zdravila bolnica še naprej doji.
• antiepileptics, (for treating epilepsy) e.g. phenytoin
• antiepileptiki (za zdravljenje epilepsije), npr. fenitoin,
Medicinal products that inhibit CYP3A4
Zdravila, ki zavirajo encim CYP3A4
Please discuss with your doctor if you need further advice.
Vprašajte zdravnika ali farmacevta, če potrebujete dodatni nasvet.
BUCCOLAM 5 mg, 7.5 mg, 10 mg oromucosal solution 2 years
BUCCOLAM 5 mg, 7,5 mg, 10 mg oralna raztopina 2 leti.
Bradycardia**, cardiac arrest**, hypotension**, vasodilatation**
bradikardija**, srčni zastoj**, hipotenzija**,
Tell the doctor if the patient is breast-feeding.
Povejte zdravniku, če bolnica doji.
• Severe liver problems.
• hude težave z jetri.
Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.
Pri bolnikih s kronično respiratorno insuficienco uporabljajte midazolam previdno, saj lahko midazolam povzroči dodatno depresijo dihanja.
Medicinal product interactions following oromucosal administration of midazolam are likely to be similar to those observed after intravenous midazolam rather than oral administration.
Medsebojno delovanje zdravil po oralnem dajanju midazolama je verjetno bolj podobno medsebojnemu delovanju pri intravenskem dajanju midazolama kot pa pri peroralnem.
There is a slow and insignificant passage of midazolam into the cerebrospinal fluid.
Prehajanje midazolama v cerebrospinalno tekočino je počasno in nepomembno.
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.
V blagih primerih simptomi vključujejo dremavost, duševno zmedenost in letargijo, pri težjih primerih pa lahko simptomi vključujejo ataksijo, hipotonijo,
The risk for new-born infants should be taken into account in the event of administration of midazolam in the third trimester of pregnancy.
Pri dajanju midazolama v tretjem trimesečju nosečnosti je treba upoštevati tveganje za novorojence.
Very rare: Apnoea**, dyspnea**, laryngospasm**, respiratory arrest**
Zelo redki: apneja**, dispneja**, laringospazem**, dihalni zastoj**
• Do not give the patient another dose of BUCCOLAM.
Če je bolniku slabo (bruha) • Bolniku ne smete dati še enega odmerka zdravila BUCCOLAM.
Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.
Midazolama ne uporabljajte pri bolnikih z anamnezo zlorabe alkohola ali mamil.
BUCCOLAM 2.5 mg oromucosal solution BUCCOLAM 5 mg oromucosal solution BUCCOLAM 7.5 mg oromucosal solution BUCCOLAM 10 mg oromucosal solution
BUCCOLAM 2,5 mg oralna raztopina BUCCOLAM 5 mg oralna raztopina BUCCOLAM 7,5 mg oralna raztopina BUCCOLAM 10 mg oralna raztopina
Severe respiratory insufficiency
Težka respiratorna insuficienca.
• The active substance is midazolam
• Zdravilna učinkovina je midazolam.
Grapefruit juice may increase the sedative effects of this medicine and make them very sleepy.
Grenivkin sok lahko poveča pomirjevalne učinke tega zdravila in bolnika naredi zelo zaspanega.
Keep the oral syringe in the protective plastic tube.
Brizgo za peroralno dajanje hranite v zaščitnem plastičnem ovitku.