FrancophonIA/ELRC3.0 huggingface dataset:
English: Mayzent is a medicine used to treat adults with an advanced form of MS known as secondary progressive MS (MS).
Slovenian: Mayzent je zdravilo, ki se uporablja za zdravljenje odraslih z napredno obliko multiple skleroze, znano kot sekundarna progresivna multipla skleroza.
English: Mayzent contains the active substance siponimod.
Slovenian: Zdravilo Mayzent vsebuje učinkovino siponimod.
English: By attaching to these receptors, siponimod stops lymphocytes from travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in MS.
Slovenian: Siponimod z vezavo na te receptorje prepreči, da bi limfociti potovali iz bezgavk do možganov in hrbtenjače, s čimer se omeji škoda, ki jo povzročijo pri multipli sklerozi.
English: The side effects with Mayzent are similar to those with another medicine (fingolimod) for MS working in a similar way, and are considered acceptable.
Slovenian: Neželeni učinki zdravila Mayzent, so podobni kot pri drugem zdravilu (fingolimod) za zdravljenje multiple skleroze, ki delujejo podobno, in se štejejo za sprejemljive.
English: Mayzent was effective at delaying the progression of secondary progressive MS in patients with active disease; however, the beneficial effects of the medicine were not demonstrated in patients without an active disease.
Slovenian: Zdravilo Mayzent je bilo učinkovito pri upočasnitvi napredovanja sekundarne progresivne multiple skleroze pri bolnikih z aktivno boleznijo, koristni učinki zdravila pa pri bolnikih brez aktivne bolezni niso bili dokazani.
English: For the full list of side effects and restrictions of Mayzent, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Mayzent glejte navodilo za uporabo.
English: Mayzent can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the management of MS.
Slovenian: Predpisovanje in izdaja zdravila Mayzent je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
English: How does Mayzent work?
Slovenian: Kako zdravilo Mayzent deluje?
English: How is Mayzent used?
Slovenian: Kako se zdravilo Mayzent uporablja?
English: Do not give more than one dose.
Slovenian: Ne dajajte več kot enega odmerka.
English: This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.
Slovenian: To je izredno pomembno, saj lahko uporaba več kot enega zdravila hkrati okrepi ali oslabi učinek teh zdravil.
English: Only move them if they are in danger from, for example, deep water, fire or sharp objects.
Slovenian: Odmaknite ga samo, če ga ogrožajo na primer globoka voda, ogenj ali ostri predmeti.
English: 1000 Brussels
Slovenian: 1000 Bruselj
English: Midazolam may be used during pregnancy if clearly necessary.
Slovenian: Midazolam se lahko uporablja med nosečnostjo, če je nujno potrebno.
English: In very rare cases breathing might stop.
Slovenian: V zelo redkih primerih se lahko dihanje ustavi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 05. september 2011
English: Maximum plasma concentration is reached within 30 minutes in children.
Slovenian: Največjo koncentracijo v plazmi pri otrocih doseže v roku 30 minut.
English: For detailed instructions on how to administer the medicinal product, see section 6.6.
Slovenian: Za podrobna navodila glede načina uporabe zdravila glejte poglavje 6.6.
English: • Sleepiness or losing consciousness
Slovenian: • zaspanost ali izgubljanje zavesti.
English: Read all of this leaflet carefully, before you start giving this medicine because it contains important information for you.
Slovenian: Pred začetkom dajanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Do not use this medicine if the packaging has been opened or damaged.
Slovenian: Ne uporabljajte tega zdravila, če je ovojnina odprta ali poškodovana.
English: • Difficulty co-ordinating muscles
Slovenian: • težave s koordiniranjem mišic;
English: Patients should be observed carefully after being given the medicine.
Slovenian: Bolnike je treba po dajanju zdravila skrbno nadzirati.
English: Standard doses are indicated below:
Slovenian: Običajni odmerki so navedeni spodaj:
English: Less than 1% of the dose is recovered in urine as unchanged medicinal product..
Slovenian: Manj kot 1 % odmerka se pojavi v urinu v nespremenjeni obliki.
English: The initial and terminal elimination half-lives are 27 and 204 minutes, respectively.
Slovenian: Začetna razpolovna doba je 27 minut in končna 204 minut.
English: Preparing to give this medicine
Slovenian: Priprava na dajanje tega zdravila
English: Support your child's head with something soft, such as a cushion or your lap.
Slovenian: Podprite otrokovo glavo z nečim mehkim, na primer z blazino ali svojim naročjem.
English: Approximately 96-98% of midazolam is bound to plasma proteins.
Slovenian: Približno 96-98% midazolama se veže na beljakovine plazme.
English: Depending on age, your child will have received one of the following doses, in specifically colour labelled packaging:
Slovenian: Odvisno od starosti bo vaš otrok prejemal enega od naslednjih odmerkov v ovojnini, označeni z značilno barvo:
English: The fraction of the dose extracted by the liver has been estimated to be 30-60%.
Slovenian: Del odmerka, ki se izloči skozi jetra, je ocenjen na 30-60 %.
English: Midazolam is almost entirely eliminated by biotransformation.
Slovenian: Midazolam se skoraj v celoti izloča z biotransformacijo.
English: • This medicine has been prescribed for your child. Do not pass it on to others.
Slovenian: - Zdravilo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
English: If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption.
Slovenian: Če praznjenje želodca ne pokaže učinka, je treba dati aktivno oglje za zmanjšanje absorpcije.
English: The information on how to give this medicine is also shown on the tube label.
Slovenian: Informacije o načinu dajanja tega zdravila so tudi na nalepki plastičnega ovitka.
English: Macrolide antibiotics
Slovenian: Makrolidni antibiotiki
English: The frequency of adverse reactions is classified as follows:
Slovenian: Pogostnost neželenih učinkov je razvrščena kot sledi:
English: Muscle relaxants
Slovenian: Mišični relaksanti
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).
Slovenian: Drugega odmerka ali ponavljajočega se odmerka pri ponovitvi epileptičnega napada po začetnem odzivu ne smete dati brez predhodnega zdravniškega nasveta (glejte poglavje 5.2).
English: Your doctor will prescribe the appropriate dose of BUCCOLAM your child needs, generally according to your child's age.
Slovenian: Zdravnik vam bo predpisal pravilni odmerek zdravila BUCCOLAM, ki ga potrebuje vaš otrok, na splošno glede na bolnikovo starost.
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.
Slovenian: Otroci, mlajši od 3 mesecev: Zdravila BUCCOLAM ne dajajte otrokom, mlajšim od 3 mesecev, ker za to starostno skupino ni dovolj informacij.
English: Even though small amounts of BUCCOLAM may pass into breast milk, it may not be necessary to stop breast-feeding.
Slovenian: Čeprav lahko majhne količine zdravila BUCCOLAM prehajajo v materino mleko, morda ne bo potrebno prenehati dojiti.
English: Altered elimination of midazolam
Slovenian: Spremenjeno izločanje midazolama
English: If the child is having a seizure, allow their body to move freely, do not try to restrain them.
Slovenian: Če ima otrok epileptični napad, mu pustite, da se telo prosto premika, ne poskušajte mu preprečevati gibanja.
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.
Slovenian: Respiratorna depresija se je pojavila s stopnjo do 5 %, čeprav je to znani zaplet konvulzijskih napadov, ki je hkrati povezan z uporabo midazolama.
English: Using the finger and thumb gently pinch and pull back the child's cheek.
Slovenian: S palcem in kazalcem nežno primite in potegnite nazaj otrokovo lice.
English: Paediatric patients aged 3 to 6 months
Slovenian: Pediatrični bolniki, stari 3 mesece do 6 mesecev
English: • If the seizure does not stop within 10 minutes, call an ambulance.
Slovenian: • Če epileptični napad v 10 minutah ne mine, pokličite reševalce.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti:
English: Concomitant use with other benzodiazepines
Slovenian: Sočasna uporaba z drugimi benzodiazepini
English: Tell your doctor or pharmacist if the patient is taking, or has recently taken, or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če bolnik jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
English: If in any doubt, call for immediate medical help if:
Slovenian: Če niste gotovi, pokličite takojšnjo medicinsko pomoč, če:
English: The bioavailability of oromucosal midazolam has been estimated at 87% in children with severe malaria and convulsions.
Slovenian: Biološka uporabnost oralnega midazolama je bila ocenjena pri 87 % otrok s težko malarijo in konvulzijami.
English: • An allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • alergijo na midazolam, benzodiazepine (kot je diazepam) ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: This medicine may cause people to forget what happened after they have been given it.
Slovenian: To zdravilo lahko povzroči, da bolniki ne vedo, kaj se je z njimi dogajalo, potem ko so prejeli to zdravilo.
English: BUCCOLAM with food and drink
Slovenian: Zdravilo BUCCOLAM skupaj s hrano in pijačo
English: This medicine may also stop some other medicines from working as well, e.g. levodopa (used to treat Parkinson's disease).
Slovenian: To zdravilo lahko tudi prepreči delovanje nekaterih drugih zdravil, npr. levodope (ki se uporablja za zdravljenje Parkinsonove bolezni).
English: Giving high doses of BUCCOLAM during the last 3 months of pregnancy can cause abnormal heart beat in the unborn child.
Slovenian: Dajanje velikih odmerkov zdravila BUCCOLAM v zadnjih 3 mesecih nosečnosti lahko povzroči nenormalen srčni utrip pri nerojenem otroku.
English: E.g. baclofen.
Slovenian: Npr. baklofen.
English: The absolute bioavailability of oromucosal midazolam is about 75% in adults.
Slovenian: Absolutna biološka razpoložljivost oralnega midazolama je pri odraslih približno 75 %.
English: The safety and efficacy of midazolam in children aged 0 to 3 months has not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost midazolama pri otrocih, starih 0 do 3 mesece, nista dokazani.
English: What BUCCOLAM is and what it is used for What you need to know before you give BUCCOLAM How to give BUCCOLAM
Slovenian: Kaj je zdravilo BUCCOLAM in za kaj ga uporabljamo Kaj morate vedeti, preden boste dali zdravilo BUCCOLAM Kako dati zdravilo BUCCOLAM
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.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom BUCCOLAM za vse skupine pediatrične populacije < 3 mesece starosti, saj to zdravilo ne kaže značilnih terapevtskih koristi glede na obstoječa zdravljenja teh pediatričnih bolnikov.
English: Antiepileptics
Slovenian: Antiepileptiki
English: What BUCCOLAM is and what it is used for
Slovenian: Kaj je zdravilo BUCCOLAM in za kaj ga uporabljamo
English: 3 to 6 months hospital setting
Slovenian: 3 do 6 mesecev bolnišnica
English: Signs may include chest pain which may spread to the child's neck and shoulders and down their left arm.
Slovenian: Med znaki so lahko bolečina v prsih, ki se lahko razširi v otrokov vrat in rame in po levici navzdol.
English: Ask a doctor, pharmacist or nurse to show you how to take or administer this medicine.
Slovenian: Prosite zdravnika, farmacevta ali medicinsko sestro, naj vam pokaže, kako se zdravilo jemlje ali daje.
English: • antihistamines (to treat allergies).
Slovenian: • antihistaminiki (za zdravljenje alergij).
English: Midazolam decreases the minimum alveolar concentration (MAC) of inhalation anaesthetics.
Slovenian: Midazolam zmanjša minimalno alveolarno koncentracijo (MAC) inhalacijskih anestetikov.
English: Each syringe is for single use only.
Slovenian: Vsaka brizga je samo za enkratno uporabo.
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.
Slovenian: Simulirani podatki o izpostavljenosti kažejo, da se celokupni AUC približno podvoji, če damo drugi odmerek 10, 30 ali 60 minut po prvem.
English: Label colour
Slovenian: Barva oznake
English: No data on exposed pregnancies are available for the first two trimesters of pregnancy.
Slovenian: Za prvi dve trimesečji nosečnosti ni podatkov o izpostavljenosti med nosečnostjo.
English: The effects of BUCCOLAM may be reduced by medicines such as:
Slovenian: Učinke zdravila BUCCOLAM lahko zmanjšajo zdravila, kot so:
English: 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.
Slovenian: V 4 študijah kontroliranih z rektalno apliciranim diazepamom in v eni študiji kontrolirani z intravenskim diazepamom pri skupaj 688 otrocih so v roku 10 minut opazili prenehanje vidnih znakov epileptičnega napada pri 65 % do 78 % otrok, ki so oralno prejeli midazolam.
English: The elimination half-life in patients with chronic renal failure is similar to that in healthy volunteers.
Slovenian: Razpolovna doba izločanja pri bolnikih s kronično odpovedjo ledvic je podobna kot pri zdravih prostovoljcih.
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.
Slovenian: V farmakokinetičnih študijah populacije so bile ravni presnovkov višje pri mlajših kot pri starejših pediatričnih bolnikih, zato so verjetno pomembnejše za otroke kot za odrasle.
English: Midazolam is highly lipophilic and distributes extensively.
Slovenian: Midazolam je zelo lipofilen in se obširno porazdeli.
English: 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.
Slovenian: − na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Babies born after this medicine is administered during childbirth can also have poor suckling, breathing difficulties and poor muscle tone at birth.
Slovenian: Otroci, ki se rodijo po dajanju tega zdravila med porodom, lahko pri rojstvu slabo sesajo, imajo težave z dihanjem in slab mišični tonus.
English: Alcohol (including alcohol-containing medicinal products may markedly enhance the sedative effect of midazolam.
Slovenian: Alkohol (vključno z zdravili, ki vsebujejo alkohol), lahko znatno okrepi sedativni učinek midazolama.
English: Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Slovenian: Posebno pozornost je treba pri intenzivni negi posvetiti dihalnim in kardiovaskularnim funkcijam.
English: • A disease of the nerves and muscles causing muscle weakness (myasthenia gravis)
Slovenian: • bolezen živcev in mišic, ki povzroča oslabelost mišic (miastenijo gravis);
English: • Reduced alertness
Slovenian: • zmanjšana pozornost;
English: The different doses each have a different colour, which is shown on the carton, the tube and the syringe containing the medicine.
Slovenian: Različni odmerki imajo vsak določeno barvo, ki je vidna na ovojnini, plastičnem ovitku in brizgi, ki vsebuje zdravilo.
English: This is due to an increase of approximately 50% in the volume of distribution corrected for total body weight.
Slovenian: To je posledica zvišanja porazdelitvenega volumna za približno 50 %, korigiranega za skupno telesno maso.
English: • antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, pozaconazole
Slovenian: • antimikotiki, npr. ketokonazol, vorikonazol, flukonazol, itrakonazol, posakonazol,
English: How to give this medicine
Slovenian: Kako dajemo to zdravilo
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.
Slovenian: Zaradi visokega razmerja presnovkov glede na izhodiščno zdravilo pri majhnih otrocih zakasnele respiratorne depresije kot posledice visoke koncentracije aktivnih presnovkov v skupini 3-6 mesecev ni mogoče izključiti.
English: Each oral syringe is individually packed in a protective plastic tube.
Slovenian: Vsaka brizga za peroralno dajanje je individualno pakirana v zaščitnem plastičnem ovitku.
English: PHARMACEUTICAL FORM Oromucosal solution Clear colourless solution pH 2.9 to 3.7
Slovenian: FARMACEVTSKA OBLIKA oralna raztopina bistra brezbarvna raztopina pH 2,9 do 3,7
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.
Slovenian: Če je bolnica, ki bo zdravilo dobila, noseča ali če doji, če meni, da bi lahko bila noseča, oziroma če načrtuje nosečnost, se posvetujte z zdravnikom, preden bo vzela to zdravilo.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Strength 2.5 mg:
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Jakost 2,5 mg
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.
Slovenian: Študije na živalih ne kažejo na teratogeno delovanje glede sposobnosti razmnoževanja, vendar so, tako kakor že pri drugih benzodiazepinih, pri ljudeh opazili fetotoksičnost.
English: Animal studies did not show an impairment of fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Common: ≥ 1/100 to < 1/10
Slovenian: ≥ 1/100 do < 1/10
English: Medical history of alcohol or drug abuse
Slovenian: Anamneza zlorabe alkohola ali mamil
English: NAME OF THE MARKETING AUTHORISATION HOLDER Shire logo
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Logotip Shire
English: 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.
Slovenian: Po prevelikem odmerjanju oralnega midazolama je treba izzvati bruhanje (v roku ene ure), če je bolnik pri zavesti, ali izprati želodec ob zaščitenih dihalnih poteh, če je bolnik nezavesten.
English: A second dose at 10 minutes results in a significant increase in mean Cmax of between 1.7 to 1.9 fold.
Slovenian: Prejem drugega odmerka po 10 minutah povzroči znatno povečanje povprečnega Cmax v razponu med 1,7- do 1,9-krat.
English: Pull the red cap off the tip of the syringe and dispose of it safely.
Slovenian: Potegnite rdeči pokrovček s konice brizge in ga varno zavrzite.
English: BUCCOLAM is not for intravenous use.
Slovenian: Zdravilo BUCCOLAM ni za intravensko uporabo.
English: Midazolam may cause anterograde amnesia.
Slovenian: Midazolam lahko povzroči anterogradno amnezijo.
English: • An illness causing frequent interruption of breathing during sleep (sleep apnoea syndrome)
Slovenian: • bolezen, ki povzroči pogosto prekinitev dihanja med spanjem (sindrom spalne apneje);
English: Published clinical studies show that oromucosal midazolam was administered to approx 443 children with seizures.
Slovenian: Objavljene klinične študije kažejo, da so oralni midazolam dajali približno 443 otrokom z epileptičnimi napadi.
English: This may affect their performance at skilled tasks such as driving, riding a bicycle, or using machines.
Slovenian: To lahko vpliva na njegovo sposobnost upravljanja vozil, vožnje s kolesom ali uporabe strojev.
English: After receiving this medicine, the patient should not drive a vehicle, ride a bicycle or operate a machine until they have completely recovered.
Slovenian: Po apliciranju tega zdravila bolnik ne sme voziti avtomobila ali kolesa ali upravljati s stroji, dokler povsem ne okreva.
English: Small quantities of midazolam are found in human milk.
Slovenian: V mleku najdemo majhne količine midazolama.
English: Check that the medicine is the correct dose for your child, according to their age.
Slovenian: Prepričajte se, da imate glede na otrokovo starost pravilen odmerek zdravila za otroka.
English: Slowly press the syringe plunger until the plunger stops.
Slovenian: Počasi pritiskajte na bat brizge, dokler se ne ustavi.
English: The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables midazolam to form the hydrochloride salt with acids.
Slovenian: Bazični dušik na 2. mestu obročnega sistema imidazobenzodiazepina omogoča midazolamu, da s kislinami tvori hidrokloridne soli.
English: Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Slovenian: Preveliko odmerjanje benzodiazepinov se običajno kaže s stopnjami depresije osrednjega živčevja, ki segajo od dremavosti do kome.
English: Syringe volume
Slovenian: Volumen brizge
English: Alcohol intake should be strongly avoided in case of midazolam administration (see section 4.4).
Slovenian: Uživanju alkohola se je treba pri dajanju midazolama močno izogibati (glejte poglavje 4.4).
English: After oromucosal administration, only systemic clearance will be affected.
Slovenian: Po oralni uporabi je prizadet le sistemski očistek.
English: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years).
Slovenian: Zdravljenje dalj časa trajajočih, akutnih epileptičnih napadov pri dojenčkih, malčkih, otrocih in mladostnikih (od starosti 3 mesecev do < 18 let).
English: Talk to your doctor or pharmacist about medicines the patient should avoid whilst taking BUCCOLAM.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom o zdravilih, ki se jim mora bolnik izogibati, medtem ko jemlje zdravilo BUCCOLAM.
English: The major fraction of plasma protein binding is due to albumin.
Slovenian: Največji del vezave na beljakovine plazme pripisujemo albuminu.