natgillin/translations-raw huggingface dataset:
Other oral antidiabetics (such as metformin) used to lower blood-glucose level
Ostali oralni antidijabetici (kao što je metformin) koji se upotrebljavaju za snižavanje razine glukoze u krvi
Maximum recommended posology (expressed as mg/kg/day) where the AMGLIDIA 0.6 mg/mL strength can be used
Maksimalna preporučena doza (izražena u mg/kg/dan) u kojoj se AMGLIDIA jačine
General aspects
Opći aspekti
If you notice any side effects, talk to your doctor or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Highly protein-bound medicinal products, which may also potentiate the hypoglycaemic action of glibenclamide due to glibenclamide displacement from plasma proteins, include oral anticoagulants, phenytoin, salicylates and other non-steroidal anti-inflammatory agents.
Lijekovi koji se u visokoj mjeri vežu za protein, a koji mogu potencirati i hipoglikemijsko djelovanje glibenklamida zbog odvajanja glibenklamida od proteina u plazmi uključuju oralne antikoagulanse,
The medicine is administered as a ready-for-use oral suspension to be given using a specific marked syringe.
Lijek se primjenjuje kao gotova oralna suspenzija pomoću posebno označene štrcaljke.
Administering glibenclamide to a diabetic enhances the post-prandial insulinotropic response.
Primjena glibenklamida u dijabetičara poboljšava inzulinotropni odgovor nakon obroka.
For severe hepatic impairment see section 4.3.
Za teško oštećenje funkcije bubrega vidjeti dio 4.3.
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.
Sulfonilureje kao što je AMGLIDIA pokazale su se djelotvornima u bolesnika s mutacijama gena koji kodiraju kalijev kanal osjetljiv na ATP u beta stanicama i prolaznim neonatalnim diabetes mellitusom povezanim s kromosomom 6q24.
Clonidine
Klonidin
Salicylates
Salicilati
For patients still under insulin at day 6, maintain the dose of AMGLIDIA for at least 4 weeks.
Bolesnici koji na 6. dan još uvijek trebaju inzulin dozu lijeka AMGLIDIA trebaju primati još najmanje
Incorrect dosage of coumarin derivatives administered
Nepravilno doziranje primijenjenih derivata kumarina
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.
U dvoje djece zabilježena je bol u trbuhu (u jednog djeteta se prolazno se istodobno pojavio proljev i povraćanje) koja se smatra povezanom s lijekom.
Keep the bottle the outer carton in order to protect from light.
Bočicu držite u vanjskom pakiranju radi zaštite od svjetla.
Only the oral syringe included in the outer carton should be used.
Smije se koristiti samo štrcaljka za usta priložena u vanjsko pakiranje.
Stimulation of insulin secretion by glibenclamide in response to a meal is of major significance.
Sposobnost glibenklamida da potiče sekreciju inzulina kao odgovor na obrok od velikog je značaja.
• 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
• Lijek Amglidia dostupan je u četiri različite kutije koje odgovaraju četirima različitim pakiranjima (četiri različite jačine): Jedna kutija za jačinu 0,6 mg/ml s jednom štrcaljkom od 1 ml: vanjska kutija žute boje i naljepnica žute boje reverzno
Outpatient treatment introduction
Uvođenje izvanbolničkog liječenja
After switching from glibenclamide tablets to AMGLIDIA suspension, there was no significant change in glycaemic control as evidenced from the similar serum HbA1c (6.5 vs 6.1% at Visits M0 and M4, respectively; p=0.076) and fructosamine (283.4 vs 271.2 µmol/L at Visits M0 and M4, respectively; p=0.55) mean concentrations.
HbA1c u serumu (6,5 u odnosu na 6.1 % pri posjetima M0 i M4; p=0,076) i fruktozamina (283,4 u odnosu na 271,2 µmol/l pri posjetima M0 i M4; p=0,55).
Hepatic impairment:
Oštećenje bubrega:
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.
U literaturi su zabilježeni i slučajevi viših doza, a doze do 2,8 mg/kg/dan uspješno su primjenjivane bez nuspojava.
• 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.
Nakon što se odredi ukupna dnevna doza i jačina lijeka koja će se primjenjivati, treba odrediti učestalost dnevne primjene, i izračunati odgovarajući volumen za primjenu.
AMMTek 55 rue de Turbigo 75003 Paris France
AMMTeK 55 rue de Turbigo 75003 Pariz Francuska
AMMTeK 55 rue de Turbigo 75003 Paris France
AMMTek 55 rue de Turbigo 75003 Pariz Francuska
Glibenclamide has been shown to be effective in patients with mutations in the genes coding for the βcell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Glibenklamid se pokazao djelotvornim u bolesnika s mutacijama gena koji kodiraju kalijev kanal beta stanica osjetljiv na ATP i prolaznim neonatalnim dijabetesom mellitusom povezanim s kromosomom 6q24.
Potentiation or weakening of the bloodglucose lowering effect
Potenciranje ili slabljenje učinka smanjenja razine glukoze u krvi
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.
Nakon oralne primjene glibenklamid se brzo apsorbira i počinje djelovati u roku od 2,5 sati.
Oxyphenbutazone
Oksifenbutazon
Blood sugar levels too low Incorrect dosage of coumarin derivatives administered
Preniske razine šećera u krvi Neodgovarajuće doze primijenjenih derivata kumarina
Under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
Pod utjecajem simpatolitičkih lijekova kao što su beta-blokatori, klonidin, gvanetidin i rezerpin,
Close monitoring of blood-glucose by the patient's family must be continued until the family and the physician, if he/she had to be contacted, are certain that the patient is out of danger.
Obitelj bolesnika treba nastaviti pažljivo pratiti razinu glukoze u krvi dok obitelj i liječnik (treba mu se obratiti prema potrebi)
Large doses of laxatives Weakening of the blood-glucoselowering effect
Velike doze laksativa Slabljenje učinka smanjenja razine glukoze u krvi
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.
Liječenje lijekom AMGLIDIA potrebno je početi pri dozi od 0,2 mg/kg/dan podijeljenoj u dvije primjene te je dozu potrebno svaki tjedan postupno povećavati za 0,2 mg/kg/dan.
To be taken into consideration by patients on a controlled sodium diet.
U obzir treba uzeti za bolesnike koji su na dijeti sa smanjenim unosom natrija.
As generally recommended in such situations, if vomiting occurs less than 30 minutes following administration of AMGLIDIA, a new dose can be given.
U takvim se situacijama općenito preporučuje primjena nove doze lijeka AMGLIDIA ako do povraćanja dođe nakon manje od 30 minuta od primjene lijeka AMGLIDIA.
Open the bottle by unscrewing the child-resistant closure while pressing downwards.
Otvorite bočicu tako što ćete zatvarač siguran za djecu odvrtati uz istovremeno pritiskanje prema dolje.
For severe renal impairment see section 4.3.
Za teško oštećenje funkcije jetre vidjeti dio 4.3.
AMGLIDIA is indicated for the treatment of neonatal diabetes in newborns, infants and children.
AMGLIDIA je indicirana za liječenje neonatalnog diabetes mellitusa u novorođenčadi, dojenčadi i djece.
If capillary blood glucose is < 7 mmol/L reduce insulin.
Ako je glukoza u kapilarnoj krvi < 7 mmol/l potrebno je smanjiti dozu inzulina.
Anabolic steroids and male sex hormones (such as testosterone enanthate) (used to treat testosterone deficiency)
(kao što je testosteronenantat) (upotrebljava se za liječenje nedostatka testosterona)
- if your child is treated with bosentan, e.g. a medicine used to treat problems of blood circulation.
- ako Vaše dijete boluje od porfirije (nemogućnost razlaganja molekula porfirina u tijelu). - ako Vaše dijete prima bosentan, npr. lijek koji se koristi za liječenje problema s cirkulacijom krvi. - ako Vaše dijete boluje od teškog poremećaja funkcije bubrega.
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.
To su hitna stanja koja zahtijevaju liječenje odmah po dijagnosticiranju uzroka ili postavljanju sumnje na njega, i prije samog hitnog primanja bolesnika u bolnicu.
Give basal and bolus insulin as usual on Day 1.
Na dan 1 primijenite uobičajenu bazalnu i bolusnu inzulinsku terapiju.
How to give AMGLIDIA
Kako davati lijek AMGLIDIA
- The other ingredients are: xanthan gum, hydroxyethylcellulose, lactic acid, purified water sodium citrate and sodium benzoate (E211) (see section 2 “AMGLIDIA contains sodium and benzoate”).
natrijev citrat i natrijev benzoat (E211) (vidjeti dio 2. „AMGLIDIA sadrži natrij i benzoat“).
Increased blood-glucose levels
Povećane razine glukoze u krvi
To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA daily dose should not exceed 1 mL/kg/day.
Kako bi se izbjeglo prekoračenje prihvatljive dnevne doze natrijeva benzoata, dnevna doza lijeka
One bottle of 30 ml suspension and one oral syringe of 1 mL packed in an individual bag and one syringe adaptor.
Jedna bočica suspenzije od 30 ml i jedna štrcaljka od 1 ml za usta u jednoj vrećici te jedan nastavak za bočicu.
Sulfamethoxazole with trimethoprim (Cotrimoxazole)
Sulfametoksazol s trimetoprimom (kotrimoksazol)
It may be necessary to adjust the dosage of AMGLIDIA in patients suffering from intercurrent infections, trauma, shock or anaesthesia:
Možda će trebati prilagoditi dozu lijeka AMGLIDIA u bolesnika koji imaju interkurentnu infekciju,
These values were approx. 40% greater than those obtained for the crushed tablet (148.34 ± 46.74 ng/mL).
Te su vrijednosti bile približno 40 % veće od onih dobivenih nakon primjene zdrobljene tablete (148,34 ± 46,74 ng/ml).Izloženost je bila slična za obje oralne suspenzije glibenklamida te veća od one primijećene nakon primjene zdrobljenih tableta
One bottle of 30 ml suspension and one oral syringe of 5 mL packed in an individual bag and one syringe adaptor.
Jedna bočica suspenzije od 30 ml i jedna štrcaljka od 5 ml za usta u jednoj vrećici te jedan nastavak za bočicu.
The dose in mL per administration and the number of administrations per day have to carefully follow the medical prescription.
Doza u ml po primjeni i broj primjena na dan ne smiju odstupati od propisanog.
Both acute and chronic alcohol intake may attenuate the hypoglycaemic effect of glibenclamide or dangerously potentiate it by delaying its metabolic inactivation.
Akutni i kronični unos alkohola može umanjiti učinak glibenklamida na snižavanje razine šećera u krvi ili ga opasno pojačati odgađanjem metaboličke deaktivacije.
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
Nikotinatna kiselina (u velikim dozama) koja se upotrebljava za smanjenje visokih razina kolesterola i triglicerida, koji su masnoće u krvi
In those patients, treatment should be started at the lowest dose and dosage levels strictly followed, to avoid hypoglycaemic reactions (see section 4.4).
Treba se strogo pridržavati propisanih razina u doziranju radi izbjegavanja hipoglikemijskih reakcija (vidjeti dio 4.4).
Ifosfamide
Ifosfamid
Fibrates
Fibrati
Insert the adaptor firmly into the bottle while holding the bottle the right way up.
Čvrsto umetnite nastavak u bočicu dok je držite u uspravnom položaju.
Each mL contains 6 mg glibenclamide.
Svaki ml sadrži 6 mg glibenklamida.
The educational material is aimed at increasing awareness about the four presentations available (two strengths of the product, each containing either a 1mL or a 5mL syringe) and at minimising the risk of hypoglycaemia in case of mix-ups of the different presentations.
(dvije jačine lijeka, pri čemu svaka sadrži štrcaljku od 1 ml ili 5 ml) i na smanjenje opasnosti od hipoglikemije u slučaju zamjene različitih pakiranja.
In case of minor vomiting, an antivomiting medicine will be prescribed by your doctor and AMGLIDIA can be continued.
Vaš će Vam liječnik propisati lijek protiv povraćanja te možete nastaviti s primjenom lijeka AMGLIDIA.
If capillary blood glucose is < 7 mmol/L, do not increase AMGLIDIA and reduce pre-meal insulin boluses by 50%.
Ako je glukoza u kapilarnoj krvi <7 mmol/l, nemojte povećavati dozu lijeka AMGLIDIA,
H2-receptor antagonists Potentiation or weakening of the bloodglucose lowering effect
Antagonisti H2-receptora koji se upotrebljava za smanjenje želučane kiseline
Tritoqualine
Tritokvalin
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.
Od dana 2 do završetka faze titracije povećavajte dozu lijeka AMGLIDIA za 0,2 mg/kg/dan ako je glukoza u kapilarnoj krvi
Diazoxide
Diazoksid
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.
- jednu štrcaljku za usta od 1 ml (tanka i mala) ili jednu štrcaljku za usta od 5 ml (debela i dugačka), ovisno o propisanoj dozi i volumenu koju treba primijeniti.
Thyroid hormones (such as L-thyroxin) used for hormonal treatment
Hormoni štitnjače (na primjer L-tiroksin)
Start AMGLIDIA at a dose of 0.2 mg/kg/day, in two administration.
Liječenje lijekom AMGLIDIA počnite dozom od 0,2 mg/kg/dan podijeljenom u dvije primjene.
Progestogens
Progestogeni
This medicinal product is administered orally as a “ready for-use” oral suspension using a graduated oral syringe.
Ovaj se lijek primjenjuje peroralno kao gotova oralna suspenzija pomoću graduirane štrcaljke za usta.
Each mL contains 0.6 mg glibenclamide.
Svaki ml sadrži 0,6 mg glibenklamida.
AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension
AMGLIDIA 0,6 mg/ml oralna suspenzija AMGLIDIA 6 mg/ml oralna suspenzija
Adverse reactions (diarrhoea/nausea/reduced appetite/abdominal pain) were reported in 10/81(12%); these were transient, and no patients discontinued sulphonylurea as a result.
(proljev, mučnina, smanjeni apetit, bol u trbuhu) zabilježene su u 10 od 81 bolesnika (12 %).
The screw cap should be retightened in order to push the adaptor well into the bottle.
Navojni zatvarač se treba ponovno zategnuti kako biste nastavak gurnuli duboko u bočicu.
Glibenclamide suspension therapy should be initiated by a physician experienced in the treatment of patients with very early onset diabetes.
4.2 Doziranje i način primjene Liječenje suspenzijom glibenklamida treba uvesti liječnik s iskustvom u liječenju bolesnika s vrlo ranim pojavljivanjem dijabetesa.
Each syringe is included in a specific presentation.
Svaka štrcaljka je priložena u njoj odgovarajuće pakiranje lijeka.
Blood-glucose should be monitored periodically throughout treatment with glibenclamide.
Tijekom liječenja glibenklamidom treba povremeno provjeravati razinu glukoze u krvi.
How to store AMGLIDIA
Kako čuvati lijek AMGLIDIA
AMGLIDIA 6 mg/mL oral suspension Each mL contains 6 mg glibenclamide.
AMGLIDIA 6 mg/ml oralna suspenzija Jedan ml sadrži 6 mg glibenklamida.
Symptomatic measures were taken and the medicinal product continued and the situation resolved in the two cases.
Poduzete su simptomatske mjere, nastavljena primjena lijeka te su se u oba slučaja poremećaji povukli . U jednog se djeteta pojavila dispepsija povezana s lijekom.
Blood sugar levels too low Increased blood sugar levels Incorrect control of plasma sugar
Preniske razine šećera u krvi Povišene razine šećera u krvi Nepravilna kontrola šećera u plazmi
Phosphamides
Fosfamidi
Your child's blood sugar levels may become too low (hypoglycaemia) after taking AMGLIDIA.
Nakon primjene lijeka AMGLIDIA razina šećera u krvi Vašeg djeteta može biti preniska (hipoglikemija).
AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension glibenclamide
AMGLIDIA 0,6 mg/ml oralna suspenzija AMGLIDIA 6 mg/ml oralna suspenzija glibenklamid
AMGLIDIA 0.6 mg/mL oral suspension Each mL contains 0.6 mg glibenclamide.
AMGLIDIA 0,6 mg/ml oralna suspenzija Jedan ml sadrži 0,6 mg glibenklamida.
This may be done as an outpatient.
Stoga se ne smije propisivati za takve bolesnike.
This medicine is a ready-for-use oral suspension to be given with a marked oral syringe.
Ovaj je lijek gotova suspenzija za oralnu primjenu koja se primjenjuje pomoću označene štrcaljke za usta.
Package leaflet: Information for the user AMGLIDIA 6 mg/mL oral suspension
Uputa o lijeku: Informacije za korisnika AMGLIDIA 6 mg/ml oralna suspenzija glibenklamid
Oestrogens
Estrogeni
Thyroid hormones
Hormoni štitnjače
Weakening of the blood-glucose-lowering effect and, thus, raised blood-glucose levels may occur when taking other medicinal products.
Pri primjeni drugih lijekova može se pojaviti slabljenje učinka smanjenja razine glukoze u krvi i posljedično povećanje razine glukoze u krvi.
Fluoxetine
Fluoksetin
Hypoglycaemia may occur when taking other medicinal products.
Pri primjeni drugih lijekova može se pojaviti hipoglikemija.
- one syringe adaptor.
- promjena boje zubiju.
Package leaflet: Information for the user AMGLIDIA 0.6 mg/mL oral suspension
Uputa o lijeku: Informacije za korisnika AMGLIDIA 0,6 mg/ml oralna suspenzija glibenklamid
The signs of too low blood sugar may include: - shaking, sweating, feeling very anxious or confused, fast heart beat
- tresenje, znojenje, osjećaj velike tjeskobe ili zbunjenosti, brze otkucaje srca
Dose adjustment is required in patients with mild to moderate hepatic impairment.
Prilagodba doze potrebna je u bolesnika s blagim do umjerenim oštećenjem jetre.
Biguanides
Nuspojave
Tooth discoloration
Promjena boje zubiju
Replace the screw cap on the bottle with the adaptor.
3. Vratite zatvarač na bočicu s nastavkom.
Close the bottle by tightening the screw cap well on top of the adaptor.
Zatvorite bočicu tako što ćete čvrsto zavrnuti zatvarača na nastavak.
Blood sugar levels too low Incorrect control of plasma sugar
Preniske razine šećera u krvi Nepravilna kontrola šećera u plazmi
Colesevelam used to lower cholesterol
Kolesevelam koji se upotrebljava za smanjenje razine kolesterola
The Prescriber's Guide shall contain the following key messages:
• Vodič za propisivača, uključujući priloženi sažetak opisa svojstava lijeka Amglidia Vodič za propisivača mora sadržavati sljedeće ključne informacije:
The 5 mL syringe is thick and long and graduated in steps of 0.1 mL.
Štrcaljka od 1 ml tanka je i mala te na sebi ima oznake u koracima od 0,05 ml. Štrcaljka od 5 ml debela je i dugačka te na sebi ima oznake u koracima od 0,1 ml.
Oxypentifylline
Oksipentifilin
Weakening of the blood-glucoselowering effect
Slabljenje učinka smanjenja razine glukoze u krvi
Insulin reduction should be done using the pre-meal glucose.
Smanjenje doze inzulina potrebno je odrediti prema razini glukoze prije obroka.
Potentiation of the blood-glucose lowering
Potenciranje snižavanja razine glukoze u krvi
Dose adjustment is required in patients with mild to moderate renal impairment.
Prilagodba doze potrebna je u bolesnika s blagim do umjerenim oštećenjem bubrega
Cyclophosphamides
Ciklofosfamidi
- The other ingredients are: xanthan gum, hydroxyethylcellulose, lactic acid, purified water, sodium citrate and sodium benzoate (E211) (see section 2 “AMGLIDIA contains sodium and benzoate).
- Drugi sastojci su: ksantanska guma, hidroksietilceluloza, laktatna kiselina, pročišćena voda,
Beta-receptor blockers Potentiation of the blood-glucose lowering
Blokatori beta receptora
SN:
Tel:.
Retighten the screw cap to push the adaptor well into the bottle.
Ponovno zategnite zatvarač da biste nastavak gurnuli duboko u bočicu.
Dose adjustment is required in patients with mild to moderate renal impairment (refer to section 4.2).
Treba se strogo pridržavati propisanih razina pri doziranju radi izbjegavanja hipoglikemijskih reakcija (vidjeti dio 4.4).
Guanethidine
Gvanetidin
Chloramphenicol
Kloramfenikol
Symptomatic measures were taken and the situation resolved.
Poduzete su simptomatske mjere te poremećaj povukao.
Probenecid used to treat gout, gouty arthritis Blood sugar levels too low Progestogens (such as desogestrel, dydrogesterone) used for hormonal treatment
Progestageni (na primjer dezogestrel, didrogesteron) koji se upotrebljavaju za hormonsko liječenje
EXPIRY DATE
EXP {MM/GGGG}
Children and adolescents Don't give this medicine to children or adolescents below the age of 18 years.
Ovaj lijek se ne smije davati djeci ni adolescentima mlađima od 18 godina.
Hold this breath in for as long as possible (at least 3-4 seconds).
Zadržite dah koliko god dugo možete (najmanje 3 - 4 sekunde).
Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data):
Pojavile su se i druge nuspojave, ali njihova točna učestalost nije poznata (učestalost se ne može procijeniti iz dostupnih podataka):
Health-Related Quality of Life
Kvaliteta života vezana uz zdravlje
Not for acute use
Nije za akutnu primjenu
You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Dovoljno je da lijek inhalirate jedanput na dan jer njegov učinak traje 24 sata.
Your inhaler is now empty.
Vaš je inhalator sada prazan.
The pre-specified non-inferiority margin was 50 mL.
Unaprijed specificirana granična vrijednost za neinferiornost iznosila je 50 ml.
• weakening of the bones, leading to fractures.
• slabljenje kostiju, koje dovodi do prijeloma
Contents of the pack and other information Step-by-step instructions
Sadržaj pakiranja i druge informacije Upute za primjenu korak po korak
It is very important that you use Trelegy Ellipta every day, as instructed by your doctor.
Vrlo je važno da Trelegy Ellipta primjenjujete svakoga dana prema uputama liječnika.
There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Postoje neki pokazatelji povećanog rizika od pneumonije s povećanjem doze steroida, ali to nije uvjerljivo dokazano u svim ispitivanjima.
After this date the inhaler should no longer be used.
Nakon tog datuma inhalator se više ne smije koristiti.
If a dose is missed the next dose should be taken at the usual time the next day.
Ako bolesnik propusti dozu, sljedeću dozu treba uzeti idući dan u uobičajeno vrijeme.
• pain in the back of the mouth and throat
• bol u stražnjem dijelu usta i grlu
This shows how many doses of medicine are left in the inhaler.
Pokazuje koliko je doza ostalo u inhalatoru.
You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Možda ćete primijetiti da Vam srce kuca brže nego inače, da drhtite, imate smetnje vida, suha usta ili glavobolju.
See section 4 ‘Possible side effects' for information on symptoms to look out for while you are using this medicine.
Pogledajte dio 4. ‘Moguće nuspojave' za informacije o simptomima na koje trebate obratiti pozornost dok primjenjujete ovaj lijek.