natgillin/translations-raw huggingface dataset:
• If the patient is prescribed a different presentation, the prescriber should highlight to the patient the packaging differences between the different presentations (focus on colour differentiation, warning statements on carton, thickness and length of the provided syringe).
• Če se bolniku predpiše druga oblika zdravila, mora zdravnik, ki predpiše zdravilo, bolniku pojasniti razlike v pakiranju med različnimi oblikami zdravila (pri tem se mora osredotočiti na razlikovanje barv, opozorilne izjave na škatli ter debelino in dolžino priložene brizge).
After oral administration, glibenclamide is absorbed rapidly and induces its effect within 2.5 hours with a duration of up to 15 hours, although the elimination half-life is 5 to 10 hours.
Po peroralni uporabi se glibenklamid hitro absorbira in začne učinkovati v 2,5 ure, njegov učinek pa traja do 15 ur, čeprav je razpolovni čas izločanja 5 do 10 ur.
Based on a limited amount of published data, the use of glibenclamide during the 1st trimester does not seem to cause an increase in congenital malformations.
Na podlagi omejene količine objavljenih podatkov se zdi, da uporaba glibenklamida v prvem trimesečju ne povzroča povečanja kongenitalnih malformacij.
If no improvement is seen (unchanged insulin dose, similar glycaemic control and no improvement in neurology), AMGLIDIA should be discontinued.
Če ni videti izboljšanja (nespremenjen odmerek insulina, podoben glikemični nadzor in odsotnost nevrološkega izboljšanja), je treba zdravilo AMGLIDIA prekiniti.
The nearest volume to the calculated one should be used.
Uporabiti je treba volumen, ki je najbliže izračunanemu volumnu.
− in patients taking bosentan (see section 4.5)
− pri bolnikih, ki jemljejo bosentan (glejte poglavje 4.5);
Two cases of severe hypoglycaemia were observed, which were considered related to the medicinal product.
Ugotovljena sta bila dva primera hude hipoglikemije, za katera se smatra, da sta povezana z zdravilom.
With respect to the 2nd and 3rd trimester published data did not find fetotoxic effects.
Kar zadeva drugo in tretje trimesečje, objavljeni podatki ne kažejo fetotoksičnih učinkov.
With smaller bodyweight the concentration increased but exceeded the adult plasma levels in minimal extents only for poor metabolizers.
Pri manjši telesni masi se je koncentracija povečala, vendar je minimalno presegla ravni v plazmi pri odraslih le pri slabih presnavljalcih.
For patients still under insulin at day 6, maintain the dose of AMGLIDIA for at least 4 weeks.
Pri bolnikih, ki 6. dan še vedno uporabljajo insulin, vdržujte odmerek zdravila AMGLIDIA vsaj 4 tedne.
After enrolment, patients continued taking their usual doses of glibenclamide tablets for 1 month.
Po vključitvi v študijo so bolniki en mesec nadaljevali jemanje običajnih odmerkov tablet glibenklamida.
Glibenclamide may increase the risk of low blood sugar and therefore have a moderate influence on the ability to drive, to take part in road traffic otherwise or use machines.
Glibenklamid lahko poveča tveganje za nizke ravni sladkorja v krvi, zato ima zmeren vpliv na sposobnost vožnje, kakršno koli drugo udeležbo v cestnem prometu ali upravljanje strojev.
The conversion rate between micronised tablets and the suspension has not been established.
Stopnja pretvorbe med mikroniziranimi tabletami in suspenzijo ni bila ugotovljena.
The average dose reported in the literature (clinical trials and case reports) is of approximately 0.5 mg/kg/day.
Povprečni odmerek, o katerem so poročali v literaturi (kliničnih preskušanjih in poročilih o primerih), je približno 0,5 mg/kg/dan.
Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and are medical emergencies requiring immediate treatment as soon as the cause is diagnosed or suspected before immediately admitting the patient to hospital.
Možne so hude hipoglikemične reakcije s komo, konvulzijami ali drugimi nevrološkimi motnjami, ki so nujni zdravstveni primeri, ki zahtevajo takojšnje zdravljenje, kakor hitro se diagnosticira vzrok ali se sumi nanj, preden se bolnika nemudoma sprejme v bolnišnico.
These values were approx. 40% greater than those obtained for the crushed tablet (148.34 ± 46.74 ng/mL).
Te vrednosti so bile za približno 40 % višje od vrednosti, dobljenih za zdrobljene tablete (148,34 ± 46,74 ng/ml).
Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).
Benzoatna sol lahko poveča tveganje za zlatenico (rumeno obarvanje kože in oči) pri novorojenčkih (do 4. tedna starosti).
Glibenclamide is completely metabolised by the liver into 3 inactive metabolites excreted via bile (60%) and urine (40%); elimination is complete in 45 to 72 hours.
V jetrih se glibenklamid v celoti presnovi v 3 neaktivne presnovke, ki se izločijo prek žolča (60 %) in urina (40 %); izločanje je končano v 45 do 72 urah.
This was a phase II, single-centre, prospective, open-label, non-randomised study.
To je bila enocentrična, prospektivna, odprta, nerandomizirana študija druge faze.
Once steady state is reached, capillary blood glucose does no longer need to be daily monitored except in clinical situations at risk of metabolic unbalance (see below).
Ko se doseže stanje dinamičnega ravnovesja, ravni glukoze v kapilarni krvi ni treba več spremljati vsak dan, razen v kliničnih situacijah s tveganjem presnovnega neravnovesja (glejte spodaj).
Anabolic steroids and male sex hormones
Anabolni steroidi in moški spolni hormoni
As the dose is increased, it is usually possible to reduce and then stop the dose of insulin the patient is already receiving.
Ker se odmerek povečuje, je običajno mogoče zmanjšati in nato ukiniti odmerek insulina, ki ga bolnik že prejema.
1 x 30 mL bottle.
1 x 30 ml steklenica
Glibenclamide is strongly bound to plasma albumin (99%), which may account for certain drug interactions, but is not easily detached by acidic medicinal products.
Glibenklamid se močno veže na albumin v plazmi (99 %), kar je lahko vzrok za nekatera medsebojna delovanja zdravil, vendar ga ni mogoče enostavno izločiti s kislimi zdravili.
Special care should be taken when calculating the dose.
Pri izračunavanju odmerka je potrebna posebna previdnost.
If ketone bodies are present, an insulin injection must be given rapidly to restore the metabolic situation.
Če so prisotna ketonska telesa, je treba hitro injicirati insulin, da se ponovno vzpostavi ustrezno metabolično stanje.
Contains sodium and benzoate, see leaflet for further information.
Vsebuje natrij in benzoat, za več informacij glejte navodilo za uporabo.
Since no interaction study between glibenclamide and milk has been performed, and despite absence of food effect on glibenclamide absorption, recommendation is given to administer the suspension 15 minutes before child's milk feeding.
Ker ni bila izvedena nobena študija o medsebojnem delovanju glibenklamida in mleka in čeprav hrana ne vpliva na absorpcijo glibenklamida, se priporoča dajanje suspenzije 15 minut pred hranjenjem otroka z mlekom.
In case of milk feeding, recommendation is given to administer the suspension 15 minutes before child's milk feeding.
Če se otrok hrani z mlekom, se priporoča dajanje suspenzije 15 minut pred hranjenjem otroka z mlekom.
In some cases these high glucose values seem to settle with the normal dose of AMGLIDIA.
V nekaterih primerih je videti, da se te velike vrednosti glukoze uravnovesijo ob normalnem odmerku zdravila AMGLIDIA.
Due to strong binding of glibenclamide to proteins, dialysis is of no benefit to the patient.
Ker se glibenklamid močno veže na beljakovine, dializa bolniku ne koristi.
Clinical studies appear to suggest that CYP2C9 contributes significantly to glibenclamide metabolism in vivo.
Klinične študije kažejo, da CYP2C9 znatno prispeva k presnovi glibenklamida in vivo.
Blood affections generally reversible when treatment stops.
Krvna obolenja so običajno reverzibilna po prenehanju zdravljenja.
The Prescriber's Guide shall contain the following key messages:
Vodnik za zdravnike, ki predpisujejo zdravilo, vsebuje naslednja ključna sporočila:
This medicine is an oral suspension, to be taken by mouth, which is a more convenient treatment for newborns and young children compared to regular injections of insulin.
To zdravilo je suspenzija, ki se zaužije, kar je za novorojenčke in majhne otroke primernejše od rednih injekcij insulina.
The attending specialist should then be contacted.
Nato je treba stopiti v stik z lečečim specialistom.
There is a risk of high blood sugar.
Obstaja tveganje za visoke ravni sladkorja v krvi.
Prior to launch of Amglidia in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of an educational material for Amglidia, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred začetkom uporabe zdravila AMGLIDIA v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskim medijem, načini distribucije in vsemi drugimi vidiki programa.
One child had dyspepsia, which was considered related to the medicinal product.
En otrok je imel dispepsijo, za katero se smatra, da je povezana z zdravilom.
• Patients and/or their caretakers should be explained that: They are prescribed a dose of Amglidia in mL according to their body weight.
• Bolnikom in/ali skrbnikom je treba pojasniti, da: je odmerek zdravila AMGLIDIA v ml predpisan glede na njihovo telesno maso.
This must be followed by continuous infusion of more dilute glucose solution (10%) at the rate needed to maintain blood-glucose above 100 mg/dL (100 mg/dL = 5.5 mmol/L).
Temu mora slediti neprekinjena infuzija bolj razredčene raztopine glukoze (10 %) v hitrosti, potrebni za ohranjanje ravni glukoze v krvi nad 100 mg/dl (100 mg/dl = 5,5 mmol/l).
The syringe is packed in a transparent bag.
Brizga je zapakirana v prosojni vrečki;
Pharmacotherapeutic group: Drugs used in diabetes, sulphonylureas, ATC code: A10BB01
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, sulfonilsečnine, oznaka ATC: A10BB01
Quinolone antibiotics
Kinolonski antibiotiki
The symptoms of moderate hypoglycaemia, without loss of consciousness or neurological signs, must be completely corrected by taking sugar, adjusting the dose and/or changing dietary behaviour.
Simptome zmerne hipoglikemije, brez izgube zavesti ali nevroloških znakov, je treba v celoti odpraviti z jemanjem sladkorja, prilagoditvijo odmerka in/ali spremembo prehranjevalnih navad.
It is recommended that such patients change treatment to insulin.
Priporočljivo je, da take bolnice preidejo na zdravljenje z insulinom.
Neutropenia and transitory increased transaminases One child had punctually low leucocytes level, but close to the normal range (neutrophils 1.3×103/µL for a lower limit of normal of 1.5×103/µL).
Nevtropenija in prehodno povišane ravni transaminaz En otrok je imel trenutno nizko raven levkocitov, vendar blizu normalnih vrednosti (nevtrofilci 1,3 x 103/µl, spodnja meja normalne vrednosti je 1,5 x 103/µl).
The bottle does not need to be shaken before administration.
Steklenice pred uporabo ni treba pretresti.
- if your child is treated with bosentan, e.g. a medicine used to treat problems of blood circulation.
- če se vaš otrok zdravi z bosentanom, npr. zdravilom, ki se uporablja za zdravljenje težav s krvnim obtokom;
Make sure you have the box containing the syringe size prescribed by your doctor.
Preverite, ali imate škatlo, ki vsebuje brizgo velikosti, ki jo je predpisal zdravnik.
You should check capillary blood sugar of your child and follow the instructions described in section 4.
Preverite raven sladkorja v krvi svojega otroka in sledite navodilom iz poglavja 4.
When limited to clinical trials or prospective data collections only, the average dose decreases to 0.2 to 0.3 mg/kg/day.
Če podatke omejimo samo na klinična preskušanja ali prospektivne zbirke podatkov, se povprečni odmerek zmanjša na 0,2 do 0,3 mg/kg/dan.
Repeat the same protocol every week until insulin independence is achieved.
Enak protokol ponavljajte vsak teden, dokler ne dosežete neodvisnosti od insulina.
There is a risk of hypoglycaemia.
Obstaja tveganje za hipoglikemijo.
Glibenclamide crosses the placenta mostly in small amounts; however, transfer is highly variable among patients.
Glibenklamid prehaja skozi placento večinoma v majhnih količinah, vendar se to prehajanje med bolnicami zelo razlikuje.
You should only use the syringe which has been prescribed by your doctor.
Uporabljate lahko samo brizgo, ki jo je predpisal zdravnik.
Adrenaline (epinephrine) and other sympathomimetic agents
Adrenalin (epinefrin) in drugi simpatikomimetiki
If a hypoglycaemic coma is diagnosed or suspected, the patient should quickly receive an intravenous injection of concentrated glucose solution (0.5 g/kg body weight as a 30% glucose solution).
Če se diagnosticira hipoglikemična koma ali se sumi nanjo, mora bolnik hitro prejeti intravensko injekcijo koncentrirane raztopine glukoze (0,5 g/kg telesne mase v obliki 30 % raztopine glukoze).
In case of nausea glycaemia seems to be maintained and insulin does not need to be re-introduced until the patient is able to take the glibenclamide suspension.
V primeru navzee se glikemija očitno ohranja, zato ni treba ponovno uvesti insulina, dokler lahko bolnik jemlje suspenzijo glibenklamida.
While the child is awake, position the child in half-sitting position in the hollow of your arm, with the child's head resting on your arm.
Ko je otrok buden, ga v svojem naročju namestite v polsedeči položaj, tako da njegova glava počiva na vaši roki.
There were no reported episodes of severe hypoglycaemia.
O epizodah hude hipoglikemije niso poročali.
To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA daily dose should not exceed 1 mL/kg/day.
Za preprečitev prekoračitve sprejemljivega dnevnega odmerka natrijevega benzoata dnevni odmerek zdravila AMGLIDIA ne sme preseči 1 ml/kg/dan.
Repeat the same protocol every day until insulin independence is achieved.
Enak protokol ponavljajte vsak dan, dokler ne dosežete neodvisnosti od insulina.
If at the end of a 5 to 6-week period, there is no evidence of a response with insulin doses similar to those at starting, administration of doses up to 2 mg/kg/day for a week may be tried.
Če ob koncu pet- do šesttedenskega obdobja ni dokazov o odzivu pri odmerkih insulina, podobnih tistim na začetku, se lahko poskusi z enotedenskim dajanjem odmerkov do 2 mg/kg/dan.
Anaphylactic reaction including dyspnoea, hypotension and shock.
Anafilaktična reakcija, vključno z dispnejo, hipotenzijo in šokom.
AMGLIDIA has moderate influence on the ability to drive and use machines since glibenclamide may increase the risk of hypoglycaemia.
Zdravilo AMGLIDIA ima zmeren vpliv na sposobnost vožnje in upravljanja strojev, saj lahko glibenklamid poveča tveganje za hipoglikemijo.
Such low blood sugar should be managed by taking sugar by mouth followed by a snack or meal.
Take nizke ravni sladkorja v krvi je treba uravnavati s peroralnim jemanjem sladkorja, čemur sledi prigrizek ali obrok.
Rifampicin used to treat infections including tuberculosis
Rifampicin, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo
After such a severe episode of hypoglycaemia, the child and family should see the child's doctor to check the appropriateness of the dose of glibenclamide suspension.
Po tako hudem dogodku hipoglikemije morajo otrok in družinski člani obiskati otrokovega zdravnika ter se z njim posvetovati o ustreznosti odmerka suspenzije glibenklamida.
Diabetes symptoms may reappear and may lead to a serious disturbance of the body's metabolism with high blood levels of ketones (ketoacidosis), dehydration and disturbance of the balance of acids in the body.
Simptomi sladkorne bolezni se lahko ponovijo in povzročijo resne motnje presnove v telesu z visokimi ravnmi ketonov v krvi (ketoacidoza), dehidracijo in motnjami ravnovesja kislin v telesu.
Before each administration, it should be verified that the correct strength and syringe are used.
Pred vsakim dajanjem zdravila je treba preveriti, ali se uporabljata ustrezna jakost in brizga.
The elimination half-lives were similar for the two suspensions (almost 8 hours) and a little shorter than those observed with the crushed Daonil tablets.
Razpolovni čas izločanja je bil za obe suspenziji podoben (skoraj 8 ur) in nekoliko krajši od razpolovnega časa pri zdrobljenih tabletah zdravila Daonil.
In pregnant women insulin is recommended for blood sugar control.
Pri nosečnicah se priporoča jemanje insulina za nadzor sladkorja v krvi.
Unither Pharmaceutical Zone d'Activites Tech Espace Avenue Toussaint Catros 33185 Le Haillan FRANCE
Unither Pharmaceutical Zone d'Activites Tech Espace Avenue Toussaint Catros 33185 Le Haillan FRANCIJA
Therefore, glibenclamide should be administered at least 4 hours prior to colesevelam.
Zato je treba glibenklamid dajati vsaj 4 ure pred kolesevelamom.
In case of inability of food or beverage intake, the child should go to emergency department to get an insulin and glucose perfusion until vomiting stops.
Če otrok ni sposoben zaužiti hrane ali pijače, ga je treba odpeljati na urgentni oddelek, da prejema infuzijo insulina in glukoze, dokler se bruhanje ne ustavi.
If ketonuria is detected, you must inject insulin immediately according to the procedure defined beforehand with your child's doctor and contact him/her or his/her team for advice.
Če ugotovite ketonurijo, morate takoj injicirati insulin v skladu s postopkom, ki ga je pred tem določil zdravnik vašega otroka, in se posvetovati z zdravnikom.
Sometimes, blood-glucose concentration will fall even though the patient is on a fixed dose of AMGLIDIA.
Včasih se bo koncentracija glukoze v krvi zmanjšala, čeprav je bolnik na fiksnem odmerku zdravila AMGLIDIA.
The oral syringe in the carton should be used only with this medicine.
Peroralno brizgo v škatli lahko uporabljate samo s tem zdravilom.
If it is necessary to prescribe this medicinal product, screening should be conducted for the occurrence of any haemolysis.
Če je treba predpisati to zdravilo, je treba izvesti preverjanje glede pojavljanja kakršne koli hemolize.
If the child does not suck, slowly press the plunger of the syringe so that the suspension trickles into the mouth.
Če otrok ne sesa, počasi potisnite bat brizge, tako da začne suspenzija kapljati v usta.
Women of childbearing potential planning a pregnancy should be switched from oral glibenclamide to insulin.
Ženske v rodni dobi, ki načrtujejo nosečnost, morajo preiti s peroralnega glibenklamida na insulin.
The same child had a transient and minimal ASAT 73 IU/L, and ALAT 42 IU/L increased (normal range below 60 and 40 respectively).
Isti otrok je imel prehodno povišani najnižji vrednosti AST in ALT, 73 i.e./l oziroma 42 i.e./l (normalni vrednosti sta 60 oziroma 40).
Transient visual disturbances (blurred vision or accommodation disorder), especially early in treatment, with or without glycaemic variation.
Prehodne motnje vida (zamegljen vid ali motnja akomodacije), zlasti na začetku zdravljenja, z glikemično spremembo ali brez nje.
Tell your doctor or pharmacist if you notice any of the following side effects: - Skin rash: itching, nettle rash (urticarial), allergic skin reaction, blistering of the skin, skin inflammation.
Obvestite zdravnika ali farmacevta, če opazite katerega od naslednjih neželenih učinkov: - kožni izpuščaji, srbečica, koprivnica (urtikarija), alergijska kožna reakcija, mehurjenje, vnetje kože;
Head to head comparative pharmacokinetic data following the application of glibenclamide suspension and micronised tablets are not available.
Neposredno primerljivi farmakokinetični podatki po uporabi suspenzije glibenklamida in mikroniziranih tablet niso na voljo.
Transitory diarrhea, vomiting and abdominal pain and dyspepsia Two children had abdominal pain (one with transient diarrhea and vomiting during the same episode) that were considered related to the medicinal product.
Prehodna driska, bruhanje in bolečine v trebuhu ter dispepsija Dva otroka sta imela bolečine v trebuhu (eden s prehodno drisko in bruhanjem v isti epizodi), za katere se je štelo, da so povezane z zdravilom.
Benzoic acid and benzoates (sodium benzoate)
Benzojska kislina in benzoati (natrijev benzoat)
Patients can be discharged when no longer requiring insulin treatment, when stable on a combination of AMGLIDIA and insulin or when stable on insulin alone.
Bolnike je mogoče odpustiti iz bolnišnice, ko ne potrebujejo več zdravljenja z insulinom, so stabilni na kombinaciji z zdravilom AMGLIDIA ali so stabilni na samostojnem insulinu.
If you have any further questions on the use of this medicine, ask the doctor of your child or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom svojega otroka ali farmacevtom.
As generally recommended in such situations, if vomiting occurs less than 30 minutes following administration of AMGLIDIA, a new dose can be given.
Kot se na splošno priporoča v takih primerih, se lahko v primeru, če se bruhanje pojavi prej kot v 30 minutah po zaužitju zdravila AMGLIDIA, da nov odmerek.
The syringe must be rinsed thoroughly with water, wiped dry after each use and replaced back into the medicine's carton.
Brizgo temeljito očistite z vodo, jo po vsaki uporabi obrišite do suhega in ponovno namestite v škatlo zdravila.
Seventy-five patients (93%) remained on sulphonylurea alone at most recent follow-up and 6/81(7%) were on sulphonylurea and daily insulin.
Petinsedemdeset bolnikov (93 %) bolnikov se je pri zadnjem spremljanju še vedno zdravilo samo s sulfonilsečnino, 6/81 (7 %) bolnikov pa se je zdravilo s sulfonilsečnino in vsakodnevnim jemanjem insulina.
Bioavailability studies have demonstrated that nonmicronised tablets provide serum glibenclamide concentrations that are not bioequivalent to those from micronised tablets.
S študijami biološke uporabnosti je bilo dokazano, da nemikronizirane tablete povzročijo koncentracije glibenklamida v serumu, ki niso biološko enakovredne tistim iz mikroniziranih tablet.
Skin rash, pruritus, urticaria, allergic skin reaction.
Kožni izpuščaji, srbečica, koprivnica, alergijska kožna reakcija.
Glibenclamide may increase ciclosporin plasma concentration and potentially lead to its increased toxicity.
Glibenklamid lahko poveča koncentracijo ciklosporina v plazmi in poveča njegovo toksičnost.
Plasma clearance of glibenclamide may be prolonged in patients suffering from liver disease.
Izločanje glibenklamida iz plazme se lahko pri bolnikih z boleznijo jeter podaljša.
Microvascular complications were reported in 7/81(9%) patients; there were no macrovascular complications.
Pri 7/81 (9 %) bolnikih so poročali o mikrovaskularnih zapletih; do makrovaskularnih zapletov pa ni prišlo.
Bosentan used to treat high blood pressure in the blood vessels between the heart and the lungs.
Bosentan, ki se uporablja za zdravljenje visokega krvnega tlaka v krvnih žilah med srcem in pljuči
Care should be taken when prescribing and administering AMGLIDIA to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL).
Pri predpisovanju in dajanju zdravila AMGLIDIA je potrebna pazljivost, da se preprečijo napake pri odmerjanju zaradi zamenjave med miligrami (mg) in mililitri (ml).
Blood-glucose level must be checked immediately and AMGLIDIA taken as soon as possible.
Takoj je treba preveriti raven glukoze v krvi in čim prej vzeti zdravilo AMGLIDIA.
You should check your child's blood sugar (capillary blood sugar).
Preveriti morate raven sladkorja v krvi svojega otroka (sladkor v kapilarni krvi).
Higher doses have occasionally been reported in the literature with doses as high as 2.8 mg/kg/day without undesirable effects and with full transfer off insulin.
Občasno so v literaturi poročali o večjih odmerkih do 2,8 mg/kg/dan brez neželenih učinkov in s popolno prekinitvijo insulina.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu.