natgillin/translations-raw huggingface dataset:
Administering glibenclamide to a diabetic enhances the post-prandial insulinotropic response.
Dajanje glibenklamida sladkornemu bolniku povečuje insulinotropni odziv po obroku.
This dose is to be administrated with a provided oral syringe graduated in mL.
Ta odmerek se daje s priloženo peroralno brizgo, graduirano v ml.
Fibrates (such as bezafibrate, fenofibrate, gemfibrozil used to lower the level of fats)
Fibrati (kot so bezafibrat, fenofibrat in gemfibrozil, ki se uporabljajo za zniževanje ravni maščob)
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
The median [IQR] dose of sulfonylurea fell over the follow-up with a median [IQR] dose of 0.30 mg/kg/day [0.14-0.53] mg/kg/day at one year and of 0.23 mg/kg/day [0.12-0.41 mg/kg/day] at 10 years, p=0.03).
Mediani (interkvartalni razpon) odmerek sulfonilsečnine se je med spremljanjem z mediano (interkvartalnim razponom) odmerka 0,30 mg/kg/dan (0,14-0,53) mg/kg/dan po enem letu in 0,23 mg/kg/dan (0,12-0,41 mg/kg/dan) po 10 letih, p = 0,01) zmanjšal.
Colesevelam binds to glibenclamide and reduces glibenclamide absorption from the gastrointestinal tract.
Holesevelam se veže na glibenklamid in zmanjšuje njegovo absorpcijo iz prebavnega trakta.
Higher doses have occasionally been observed and doses up to 2.8 mg/kg/day have been successfully given without adverse reactions, according to literature.
Občasno so opazili večje odmerke, glede na literaturo pa so brez neželenih učinkov uspešno dajali odmerke do 2,8 mg/kg/dan.
Other oral antidiabetics (such as metformin) used to lower blood-glucose level
Drugi peroralni antidiabetiki (kot je metformin), ki se uporabljajo za zniževanje ravni glukoze v krvi
Thyroid hormones (such as L-thyroxin) used for hormonal treatment
Ščitnični hormoni (kot je L-tiroksin), ki se uporabljajo za hormonsko zdravljenje
− in patients with severe hepatic impairment
− pri bolnikih s hudo okvaro jeter.
In patients on sulphonylurea alone, blood glucose control has been improved after transfer to sulfonylureas with median [IQR] HbA1c of 5.9% [5.4-6.5%] at 1 year vs 8.0 % [7.2-9.2 %] before transfer (p< 0.0001), and remained very well controlled after 10 years with a median [IQR] HbA1c of 6.4% [5.9-7.2 %].
Pri bolnikih, ki so se zdravili samo s sulfonilsečnino, se je nadzor ravni glukoze v krvi izboljšal po prehodu na sulfonilsečnine, pri čemer je bila mediana vrednost HbA1c (interkvartilni razpon) 5,9 % (5,4-6,5 %) po enem letu v primerjavi z 8,0 % (7,2-9,2 %) pred prehodom (p < 0,0001).
Chloramphenicol (in case of oral route) is an antibiotic used to treat infections
Kloramfenikol (v primeru zaužitja) je antibiotik, ki se uporablja za zdravljenje okužb
Incorrect control of plasma sugar
Nepravilen nadzor sladkorja v plazmi
Higher doses of AMGLIDIA can be given as needed and administered in up to four intakes per day, based on blood-glucose monitoring, as per titration recommendations given by the referring doctor.
Po potrebi se lahko dajejo večji odmerki zdravila AMGLIDIA, ki se dajejo v štirih ločenih dnevnih odmerkih, in sicer na podlagi spremljanja ravni glukoze v krvi ter v skladu s priporočili lečečega zdravnika glede prilaganja odmerkov.
Biliary excretion of the metabolites increases in the event of kidney failure, proportionally to the severity of the change in renal function.
Izločanje presnovkov prek žolča se v primeru odpovedi ledvic poveča sorazmerno z resnostjo spremembe delovanja ledvic.
From Day 2 until the end of the titration phase, if capillary blood glucose is ≥7 mmol/L, increase AMGLIDIA by 0.2 mg/kg/day.
Če je od drugega dneva do konca faze titracije raven glukoze v kapilarni krvi ≥ 7 mmol/l, povečajte odmerek zdravila AMGLIDIA za 0,2 mg/kg/dan.
Incorrect control of plasma glucose
Nepravilen nadzor glukoze v plazmi
No interaction was observed when glibenclamide was taken at least 4 hours before colesevelam.
V primeru jemanja glibenklamida vsaj 4 ure pred jemanjem kolesevelama ni bilo ugotovljenega medsebojnega delovanja.
− in patients with severe renal impairment
− pri bolnikih s hudo okvaro ledvic;
• A Prescriber's Guide, including the SmPC of Amglidia attached
• Vodnik za zdravnike, ki predpisujejo zdravilo, vključno s priloženim povzetkom glavnih značilnosti zdravila AMGLIDIA
Abnormal blood test results (very common: may affect more than 1 in 10 people) Laboratory blood tests may show changes in blood cells (decrease in white blood cells: leucopenia) and effects on liver function (brief increase in enzymes called transaminases).
Nenormalni rezultati krvnih testov (zelo pogosti: lahko se pojavijo pri več kot 1 od 10 bolnikov): Laboratorijski krvni testi lahko pokažejo spremembe krvnih celic (zmanjšanje števila belih krvničk:
The starting dose of AMGLIDIA is 0.2 mg of glibenclamide for each kilogram (kg) of body weight daily, divided in two doses of 0.1 mg/kg.
Začetni odmerek zdravila AMGLIDIA je 0,2 mg glibenklamida za vsak kilogram (kg) telesne mase, ki se razdeli na dva odmerka po 0,1 mg/kg.
How to give AMGLIDIA
Kako dajati zdravilo AMGLIDIA
EXP {MM/YYYY} After opening, keep the bottle tightly closed after each use and stored for a maximum of 30 days.
EXP {MM/LLLL} Po odprtju steklenico po vsaki uporabi dobro zaprite in jo hranite največ 30 dni.
Insulin reduction should be done using the pre-meal glucose.
Odmerek insulina je treba zmanjšati glede na raven glukoze pred obrokom.
Sulphonylureas like AMGLIDIA have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Sulfonilsečnine, kot je zdravilo AMGLIDIA, so se izkazale za učinkovite pri bolnikih z mutacijami genov, ki kodirajo od ATP odvisne kalijeve kanalčke celic beta, in s kromosomom 6q24 povezano prehodno sladkorno boleznijo pri novorojenčkih.
The dose in mL per administration and the number of administrations per day have to carefully follow the medical prescription.
Odmerek v ml na aplikacijo in število aplikacij na dan morajo biti povsem skladni z zdravniškim receptom.
Patients with renal impairment should be monitored periodically during treatment due to the increased risk of hypoglycaemia.
Bolnike z okvaro ledvic je treba zaradi povečanega tveganja hipoglikemije redno spremljati skozi celotno zdravljenje.
AMGLIDIA should be introduced at a dose of 0.2 mg/kg/day in two administration and dose should be progressively increased each week by 0.2 mg/kg/day.
Zdravljenje z zdravilom AMGLIDIA je treba začeti z odmerkom 0,2 mg/kg/dan v dveh ločenih odmerkih in ga je treba vsak teden postopoma večati za 0,2 mg/kg/dan.
Blood disorders
Krvne bolezni
- one syringe adaptor.
- en nastavek za brizgo.
How to store AMGLIDIA 6.
Shranjevanje zdravila AMGLIDIA 6.
• Amglidia is available in four different boxes corresponding to four different presentations (four different strengths): One box for the 0.6 mg/mL strength with one 1mL syringe: yellow colour for outer carton and reverse type yellow colour for label One box for the 0.6 mg/mL strength with one 5 mL syringe: yellow colour for outer carton and reverse type yellow colour for label One box for the 6 mg/mL strength with one syringe of 1 mL: purple colour for outer carton and reverse type purple colour for label One box for the 6 mg/mL strength with one syringe of 5 mL: purple colour for outer carton and reverse type purple colour for label
ena škatla za jakost 0,6 mg/ml z eno 1 ml brizgo: škatla rumene barve in nalepka na steklenici rumene barve s svetlejšim besedilom; ena škatla za jakost 0,6 mg/ml z eno 5 ml brizgo: škatla rumene barve in nalepka na steklenici rumene barve s svetlejšim besedilom; ena škatla za jakost 6 mg/ml z eno 1 ml brizgo: škatla rumene barve in nalepka na steklenici rumene barve s svetlejšim besedilom; ena škatla za jakost 6 mg/ml z eno 5 ml brizgo škatla rumene barve in nalepka na steklenici rumene barve s svetlejšim besedilom.
Hypoglycaemia may occur when taking other medicinal products.
Pri jemanju drugih zdravil se lahko pojavi hipoglikemija.
This medicine contains 5 mg benzoate salt in each mL oral suspension.
To zdravilo vsebuje 5 mg benzoatne soli v enem ml peroralne suspenzije.
Patients with hepatic impairment should be monitored periodically during treatment due to the increased risk of hypoglycaemia.
Bolnike z okvaro jeter je treba zaradi povečanega tveganja hipoglikemije redno spremljati skozi celotno zdravljenje.
Diuretics (such as furosemide, hydrochlorothiazide) used to treat arterial hypertension
Diuretiki (kot sta furosemid in hidroklorotiazid), ki se uporabljajo za zdravljenje arterijske hipertenzije
Both acute and chronic alcohol intake may attenuate the hypoglycaemic effect of glibenclamide or dangerously potentiate it by delaying its metabolic inactivation.
Akutno ali kronično uživanje alkohola lahko oslabi hipoglikemični učinek glibenklamida ali ga nevarno potencira z odložitvijo metabolične inaktivacije.
Sulfamethoxazole with trimethoprim (Cotrimoxazole) used to treat infections
Sulfametoksazol s trimetoprimom (kotrimoksazol), ki se uporablja za zdravljenje okužb
At the first use, the bottle should be opened by unscrewing the child-resistant closure while pressing downwards.
Ob prvi uporabi odprite steklenico tako, da odvijete za otroke varno zapiralo, medtem ko ga potiskate navzdol.
Acetazolamide (used to treat glaucoma)
Acetazolamid (ki se uporablja za zdravljenje glavkoma)
If you notice any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
- The active substance is glibenclamide.
- Učinkovina je glibenklamid.
This medicinal product contains 2.8 mg of sodium per mL oral suspension, equivalent to 0.1% of the WHO recommended daily intake of 2 g sodium for an adult.
To zdravilo vsebuje 2,8 mg natrija na ml peroralne suspenzije, kar je enako 0,1 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
Sulphonylureas will act on pancreatic beta-cells by inhibiting ATP-sensitive potassium channels.
Mehanizem delovanja Sulfonilsečnine delujejo na celice beta trebušne slinavke, tako da zavirajo od ATP odvisne kalijeve kanalčke.
Blood-glucose should be monitored periodically throughout treatment with glibenclamide.
Skozi celotno zdravljenje z glibenklamidom je treba redno spremljati raven glukoze v krvi.
Only the oral syringe included in the carton should be used.
Uporabi se lahko le peroralna brizga, ki je priložena v škatli.
Effect of interaction
Zdravilna učinkovina Učinek medsebojnega delovanja
One bottle of 30 ml suspension and one oral syringe of 5 mL packed in an individual bag and one syringe adaptor.
Ena steklenica 30 ml suspenzije in ena 5 ml peroralna brizga, pakirana v posamezni vrečki, ter en nastavek za brizgo.
Quinolone antibiotics (such as nalidixic acid and ciprofloxacine) used to treat infections
Kinolonski antibiotiki (kot sta nalidiksična kislina in ciprofloksacin), ki se uporabljajo za zdravljenje okužb
Open the bottle by unscrewing the child-resistant closure while pressing downwards (figure
Odprite steklenico tako, da odvijete za otroke varno zapiralo, medtem ko ga potiskate navzdol (slika 1).
Potentiation or weakening of the bloodglucose lowering effect
Potenciranje ali slabitev učinka zniževanja ravni glukoze v krvi
If there is minor vomiting, an antivomiting medicinal product should be given and treatment with AMGLIDIA can be continued.
V primeru blagega bruhanja zdravnik predpiše zdravilo proti bruhanju in zdravljenje z zdravilom AMGLIDIA se lahko nadaljuje.
One bottle of 30 ml suspension and one oral syringe of 1 mL packed in an individual bag and one syringe adaptor.
Ena steklenica 30 ml suspenzije in ena 1 ml peroralna brizga, pakirana v posamezni vrečki, ter en nastavek za brizgo.
Transitory increased transaminases
Prehodno zvišana raven transaminaz
The 5 mL syringe has to be used for volumes greater than 1 mL.
Za volumne, večje od 1 ml, je treba uporabiti 5 ml brizgo.
- if your child suffers from severe renal dysfunction.
- če ima vaš otrok hudo okvaro ledvic;
Each carton contains: - 1 bottle containing 30 mL oral suspension - one 1 mL oral syringe (thin and small) or one 5 mL oral syringe (thick and long) depending on the prescribed dose and the volume to be given.
Vsaka škatla vsebuje: - 1 steklenico, ki vsebuje 30 ml peroralno suspenzijo; - eno 1 ml peroralno brizgo (tanko in kratko) ali eno 5 ml peroralno brizgo (debelo in dolgo),
Tetracycline antibiotics (such as doxycycline and minocycline) used to treat infections
Tetraciklinski antibiotiki (kot sta doksiciklin in minociklin), ki se uporabljajo za zdravljenje okužb
From week 2 onward, if capillary blood glucose is ≥7 mmol/L increase AMGLIDIA by 0.2 mg/kg/day and reduce insulin.
Če je od drugega tedna naprej raven glukoze v kapilarni krvi ≥ 7 mmol/l, povečajte odmerek zdravila AMGLIDIA za 0,2 mg/kg/dan in zmanjšajte odmerek insulina.
• The prescription should state the calculated daily dose in mL, the strength of Amglidia to be used, the number of administrations over which the daily dose is divided, as well as the volume in mL to be administered for each dose and the size of the syringe to be used.
ki bo uporabljena, število dajanj, s katerim se deli dnevni odmerek, volumen v ml, ki ga je treba uporabiti za vsak odmerek, in velikost brizge, ki jo je treba uporabiti.
AMGLIDIA is to be used for newborns, infants and children.
Zdravilo AMGLIDIA se uporablja pri novorojenčkih, dojenčkih in otrocih.
- if your child suffers from porphyria (inability to break down body chemicals called porphyrins).
- če ima vaš otrok ketoacidozo (visoke ravni kislih snovi, imenovanih ketoni, v krvi); - če ima vaš otrok porfirijo (nezmožnost razgradnje snovi, imenovanih porfirini, v telesu);
Diarrhea, nausea and vomiting
Driska, navzea in bruhanje
Tetracycline compounds Potentiation of the blood-glucose lowering
Tetraciklinijeve spojine Potenciranje zniževanja ravni glukoze v krvi
No interaction studies have been performed for the two oral suspensions of glibenclamide (0.6 mg/mL and 6 mg/mL).
Za peroralni suspenziji glibenklamida (0,6 mg/ml in 6 mg/ml) niso bile izvedene študije o medsebojnem delovanju.
Talk to your doctor before your child is given AMGLIDIA.
Pred dajanjem zdravila AMGLIDIA otroku se posvetujte z zdravnikom.
AMGLIDIA therapy should be initiated at 0.2 mg/kg per day in two divided doses before feeding (including bottle feeding) and increased by 0.2 mg/kg/day until insulin independence is achieved.
Zdravljenje z zdravilom AMGLIDIA je treba začeti z odmerkom 0,2 mg/kg na dan v dveh ločenih odmerkih pred hranjenjem (vključno s hranjenjem po steklenički), potem pa ga povečati na
The bottle must be closed after each use and stored for a maximum of 30 days.
Steklenico po vsaki uporabi zaprite in jo hranite največ 30 dni.
The 5 mL syringe is thick and long and graduated in steps of 0.1 mL.
1 ml brizga je tanka in kratka ter graduirana po 0,05 ml. 5 ml brizga je debela in dolga ter graduirana po 0,1 ml.
Incorrect dosage of coumarin derivatives administered
Nepravilni dani odmerki derivatov kumarina
In a phase II, single-centre, prospective, open-label, non-randomised study, acceptability, efficiency and tolerance of the switch from crushed tablets to Amglidia suspension were measured.
V enocentrični, prospektivni, odprti, nerandomizirani študiji druge faze so se merile sprejemljivost,
Nausea, vomiting, flushing, dizziness, headache, chest and abdominal discomfort, and general hangover-like symptoms among others have occurred following the concomitant use of alcohol and glibenclamide.
Pri sočasni uporabi alkohola in glibenklamida so se pojavili slabost, bruhanje, rdečica, omotičnost, glavobol, neprijeten občutek v prsnem košu in trebuhu ter splošni simptomi, podobni simptomom po prekrokani noči.
After opening, keep the bottle tightly closed after each use and stored for a maximum of 30 days.
Po odprtju steklenico po vsaki uporabi dobro zaprite in jo hranite največ 30 dni.
Salicylates (such as aminosalicylic acid, para-aminosalicylic acid used for tuberculosis)
Salicilati (kot sta aminosalicilna kislina in paraaminosalicilna kislina), ki se uporabljajo za zdravljenje tuberkuloze
Open the bottle by unscrewing the child-resistant closure while pressing downwards.
Odprite steklenico tako, da odvijete za otroke varno zapiralo, medtem ko ga potiskate navzdol.
Glibenclamide suspension therapy should be initiated by a physician experienced in the treatment of patients with very early onset diabetes.
4.2 Odmerjanje in način uporabe Zdravljenje s suspenzijo glibenklamida mora začeti zdravnik, ki ima izkušnje z zdravljenjem bolnikov s sladkorno boleznijo, ki se pojavi v zelo zgodnjem obdobju.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
This medicine is a ready-for-use oral suspension to be given with a marked oral syringe.
To zdravilo je peroralna suspenzija, pripravljena-za-uporabo, ki se daje z označeno peroralno brizgo.
AMGLIDIA is indicated for the treatment of neonatal diabetes in newborns, infants and children.
Zdravilo AMGLIDIA je indicirano za zdravljenje sladkorne bolezni pri novorojenčkih, dojenčkih in otrocih.
Increased blood-glucose levels
Povišane ravni glukoze v krvi
AMGLIDIA should not be used in patients with insulin-dependent type 1 diabetes mellitus with evidence of auto-immune destruction of beta cells.
Zdravilo AMGLIDIA se ne sme uporabljati pri bolnikih z od insulina odvisno sladkorno boleznijo tipa
• Choice of the syringe to be used: After the total daily dose and the strength to be used have been defined, the frequency of the daily administration should be pointed out and the corresponding volume per administration should be calculated.
Po določitvi skupnega dnevnega odmerka in jakosti, ki jo je treba uporabiti, je treba izpostaviti pogostost vsakodnevnega dajanja zdravila ter izračunati ustrezen volumen zdravila za dajanje.
Close the bottle by tightening the screw cap well on top of the adaptor.
Zaprite steklenico, tako da dobro privijete pokrovček z navojem na vrh nastavka.
Blood and lymphatic system disorders Neutropenia Metabolism and nutrition disorders Hypoglycaemia Gastrointestinal disorders
Bolezni krvi in limfatičnega sistema Nevtropenija Presnovne in prehranske motnje
Your child's blood sugar levels may become too low (hypoglycaemia) after taking AMGLIDIA.
Po zaužitju zdravila AMGLIDIA lahko ravni sladkorja v krvi pri vašem otroku postanejo prenizke (hipoglikemija).
Dose adjustment is required in patients with mild to moderate renal impairment (refer to section 4.2).
Pri bolnikih z blago do zmerno okvaro ledvic je treba odmerek prilagoditi (glejte poglavje 4.2).
Blood sugar levels too low Incorrect dosage of coumarin derivatives administered
Prenizke ravni sladkorja v krvi Nepravilni dani odmerki derivatov kumarina
Miconazole used to treat fungal infection Blood sugar levels too low Nicotinic acid (in high doses) used to decrease high levels of cholesterol and triglycerides which are fat-like substances in the blood
Nikotinska kislina (v velikih odmerkih), ki se uporablja za zniževanje visokih ravni holesterola in trigliceridov, ki so maščobam podobne snovi v krvi
Biguanides (such as metformin) used to treat diabetes mellitus
Bigvanidi (kot je merformin), ki se uporabljajo za zdravljenje sladkorne bolezni
You must talk to a doctor if your child does not feel better or if he/she feels worse after a few days.
Če se znaki bolezni vašega otroka poslabšajo ali ne izboljšajo v nekaj dneh, se posvetujte z zdravnikom.
Disulfiram-like reactions have occurred very rarely following the concomitant use of alcohol and glibenclamide.
Zelo redko se po sočasnem uživanju alkohola in glibenklamida pojavijo reakcije, ki so podobne reakcijam, ki jih sproži disulfram.
Weakening of the blood-glucose-lowering effect and, thus, raised blood-glucose levels may occur when taking other medicinal products.
V primeru jemanja drugih zdravil lahko učinek zniževanja ravni glukoze v krvi oslabi in s tem se zviša raven glukoze v krvi.
Hypoglycaemia can occur under treatment with hypoglycaemic sulphonamides.
Pri zdravljenju s hipoglikemičnimi sulfonamidi se lahko pojavi hipoglikemija.
- Other laboratory blood tests changes: increased levels of the white blood cells called eosinophils
- začasne motnje vida; - druge spremembe, ki jih pokažejo laboratorijski krvni testi: povišane ravni belih krvničk,
Replace the screw cap on the bottle with the adaptor.
Pokrovček z navojem ponovno namestite na steklenico z nastavkom.
Blood sugar levels too low Incorrect control of plasma sugar low blood sugar levels may be hidden
Prenizke ravni sladkorja v krvi Nepravilen nadzor sladkorja v plazmi; nizke ravni sladkorja v krvi so lahko prikrite
Holding the bottle the right way up, insert the syringe firmly into the adaptor fitted to the bottle (figure 2).
Držite steklenico pokonci in brizgo čvrsto vstavite v nastavek, nameščen na steklenico
Prescription instructions
Navodila za predpisovanje zdravila
Insert the adaptor firmly into the bottle while holding the bottle the right way up.
Nastavek čvrsto vstavite v steklenico, pri tem jo držite pokonci.
Each mL contains 6 mg glibenclamide.
En ml vsebuje 6 mg glibenklamida.
Tooth discoloration
Bruhanje Dispepsija
Always use this medicine exactly as your doctor or pharmacist has told you.
Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
Too low blood sugar (hypoglycaemia) (very common: may affect more than 1 in 10 people) If you take AMGLIDIA, you are at risk of getting too low blood sugar (hypoglycaemia).
Prenizka raven sladkorja v krvi (hipoglikemija) (zelo pogosta: lahko se pojavi pri več kot 1 od 10 bolnikov)
How to store AMGLIDIA
Shranjevanje zdravila AMGLIDIA
Gastro intestinal disorders (very common: may affect more than 1 in 10 people): - Diarrhea - Abdominal (belly) pain - Vomiting - Stomach ache (Dyspepsia)
Želodčno-črevesne motnje (zelo pogoste: lahko se pojavijo pri več kot 1 od 10 bolnikov): - driska
You must check your child's blood sugar (capillary blood sugar) and give AMGLIDIA as soon as you realise you have forgotten to use it.
Preveriti morate raven sladkorja v krvi svojega otroka (sladkor v kapilarni krvi) in dati zdravilo
Start AMGLIDIA at a dose of 0.2 mg/kg/day, in two administration.
AMGLIDIA za 0,2 mg/kg/dan.
Each mL contains 0.6 mg glibenclamide.
En ml vsebuje 0,6 mg glibenklamida.
See your doctor, nurse or your hospital pharmacist immediately.
Če ste otroku dali večji odmerek zdravila AMGLIDIA, kot bi smeli Nemudoma obiščite zdravnika, medicinsko sestro ali farmacevta v bolnišnici.
Dose adjustment is required in patients with mild to moderate hepatic impairment.
Pri bolnikih z blago do zmerno okvaro jeter je treba odmerek prilagoditi.
In case of major vomiting, ketonemia and ketonuria should be closely monitored by the treating doctor.
V primeru hudega bruhanja mora lečeči zdravnik otroka skrbno spremljati glede ketonemije in ketonurije.
AMGLIDIA is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.
Zdravilo AMGLIDIA je indicirano za zdravljenje sladkorne bolezni, za uporabo pri novorojenčkih,
Tell the doctor if your child is pale, sweating, has irregular heart rhythm or seems disoriented, confused or unresponsive.
Če se pri vašem otroku pojavijo bledica, potenje ali neenakomerno bitje srca ali se zdi, da je otrok dezorientiran, zmeden ali neodziven, o tem obvestite zdravnika.
Package leaflet: Information for the user AMGLIDIA 6 mg/mL oral suspension
Navodilo za uporabo: informacije za uporabnika AMGLIDIA 6 mg/ml peroralna suspenzija glibenklamid
(hypereosinophilia), mild to severe decrease in blood components called platelets
imenovanih eozinofilci (hipereozinofilija), blago do močno zmanjšanje števila komponent krvi,
On Day 2, if administered sub-cutaneously, basal insulin can be removed.
Če se bazalni insulin daje subkutano, se lahko drugi dan ukine.