natgillin/translations-raw huggingface dataset:
Contact the doctor if your child has these effects suicide attempt other eye problems such as retinal disorder, causing, for example, poor vision at night and difficulty adjusting from bright to dim areas, sudden or unexplained loss of vision, sensitivity to light
druge težave z očmi, kot je bolezen mrežnice, ki na primer povzroča slab nočni vid in težave pri prilagajanju na prehod iz svetlih na zatemnjena območja, nenadna ali nepojasnjena izguba vida, občutljivost na svetlobo.
Common Uncommon Rare Very rare Not known
Neznana pogostnost
You must speak to your child's doctor if your child's condition does not improve within a month of starting vigabatrin.
Če se stanje vašega otroka v enem mesecu po začetku zdravljenja z vigabatrinom ne spremeni, morate govoriti z njegovim zdravnikom.
Ös te rreich
Okvara ledvic
Visual field defects
Izpadi vidnega polja
Dose (mg per day)
Odmerek (mg na dan)
Musculoskel etal and connective tissue disorders arthralgia
Bolezni mišičnoskeletnega sistema in vezivnega artralgija tkiva
Table 1: Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms Body we ight (kg)
Preglednica 1: število tablet za peroralno raztopino glede na telesno maso, začetni odmerek in povečanje odmerka pri infantilnih spazmih
The clinical significance of these MRI abnormalities is unknown.
Klinična pomembnost teh nepravilnosti pri slikanju z magnetno resonanco ni znana.
Such reactions have been fully reversible following dose reduction or discontinuation of vigabatrin (see section 4.4).
Takšne reakcije so bile po zmanjšanju odmerka ali prekinitvi zdravljenja z vigabatrinom popolnoma reverzibilne (glejte poglavje 4.4).
• The mixture will be whitish and cloudy.
• Mešanica bo belkasta in motna.
However, the VFDs reported in patients receiving vigabatrin have ranged from mild to severe.
Vendar so bili izpadi vidnega polja pri bolnikih, ki so prejemali vigabatrin, blagi do resni.
All patients should have ophthalmological consultation before or shortly after the initiation of vigabatrin treatment.
Pred začetkom zdravljenja z vigabatrinom ali kmalu po njem morajo vsi bolniki opraviti oftalmološki ppregled.
If you stop giving Kigabeq to your child
Če otroku prenehate dajati zdravilo Kigabeq
The adverse reactions listed below have been reported during pre- or post-approval use of vigabatrin worldwide.
Med uporabo vigabatrina pred odobritvijo in po njej so po vsem svetu poročali o spodaj naštetih neželenih učinkih.
movement disorders, including dystonia, dyskinesia and hypertonia, either alone or in association with abnormalities in MRI
vključno z distonijo, diskinezijo in hipertonijo, samostojno ali v povezavi z nepravilnostmi pri slikanju z magnetno resonanco
Abrupt withdrawal may lead to rebound seizures.
Nenadno prenehanje zdravljenja lahko povzroči ponovne („rebound‟) napade.
100 mg tablet size: 9.4 mm x 5.3 mm 500 mg tablet size: 16.0 mm x 9.0 mm
100 mg, velikost tablete: 9,4 mm x 5,3 mm 500 mg, velikost tablete: 16,0 mm x 9,0 mm
In resistant partial epilepsy (focal onset seizures), the recommended starting dose is 40 milligrams per kilogram daily.
Pri rezistentni delni epilepsiji (napadih žariščnega izvora) je priporočeni začetni odmerek 40 miligramov na kilogram dnevno.
The plasma concentrations of carbamazepine, phenobarbital, and sodium valproate have also been monitored during controlled clinical trials and no clinically significant interactions have been detected.
fenobarbitala in natrijevega valproata ter niso opazili nobenega klinično pomembnega medsebojnega delovanja.
Kigabeq is for oral or gastric administration twice daily and may be taken before or after meals.
Zdravilo Kigabeq se daje peroralno ali prek gastrične sonde dvakrat dnevno in ga je mogoče jemati pred obroki ali po njih.
Talk to your child's doctor before you give Kigabeq if your child: has or has had depression or any other psychiatric illness in the past has had any kidney problems as he/she could develop symptoms like sedation or confusion has had any eye problems.
Preden zdravilo Kigabeq daste otroku, se posvetujte z njegovim zdravnikom, če ima vaš otrok: - depresijo ali katero koli drugo psihiatrično bolezen ali jo je imel v preteklosti;
Visual Field Defects (VFD)
Peroralni očistek (Cl/F)
The onset is usually after months to years of vigabatrin therapy.
Ti izpadi običajno nastopijo več mesecev ali let po zdravljenju z vigabatrinom.
In infantile spasms (West's Syndrome), the recommended starting dose is 50 milligrams per kilogram bodyweight daily.
Pri infantilnih spazmih (Westovem sindromu) je priporočeni začetni odmerek 50 miligramov na kilogram telesne mase dnevno.
The resulting solution is whitish and cloudy.
Raztopina, ki nastane, je belkasta in motna.
Visual field defects which can significantly affect the ability to perform hazardous activities have been frequently reported in association with vigabatrin.
V povezavi z vigabatrinom so pogosto poročali o izpadih vidnega polja, ki lahko pomembno vplivajo na sposobnost izvajanja nevarnih dejavnosti.
These side effects usually stop when vigabatrin doses are reduced or the medicine is gradually discontinued.
Ti neželeni učinki običajno izginejo ob zmanjšanju odmerkov vigabatrina ali ob postopni ukinitvi zdravila.
Group I 1
PRILOGA I
Visual disorders, which can affect the ability to cycle, climb or take part in hazardous activity, have occurred in some patients taking this medicine.
Pri nekaterih bolnikih, ki jemljejo to zdravilo, so se pojavile motnje vida, ki lahko vplivajo na sposobnost kolesarjenja, plezanja ali sodelovanja pri nevarnih dejavnostih.
These events have been reversible following dose reduction or discontinuation of vigabatrin (see section 4.8).
Ti dogodki so bili po zmanjšanju odmerka ali prekinitvi zdravljenja z vigabatrinom reverzibilni (glejte poglavje 4.8).
Monotherapy for infantile spasms (West's Syndrome)
zdravljenje infantilnih spazmov (Westovega sindroma) z monoterapijo;
Abnormal Magnetic Resonance Imaging (MRI) signal changes characterised by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin for infantile spasms.
Pri nekaterih dojenčkih, ki so bili z vigabatrinom zdravljeni zaradi infantilnih spazmov, so pri slikanju z magnetno resonanco (MRI), opazili spremembe signala, ki jih opredeljujeta povečani signal T2 in omejena difuzija v simetričnem vzorcu, ki vključuje talamus, bazalne ganglije, možgansko deblo in male možgane.
The active substance is vigabatrin.
- Učinkovina je vigabatrin.
optic atrophy
optična atrofija
Visual field loss (loss of sight from the edges of your child's field of vision) may occur during treatment with vigabatrin.
Med zdravljenjem z vigabatrinom lahko pride do izpada vidnega polja (izgube vida na robovih otrokovega vidnega polja).
Pooled data from prevalence surveys suggest that as many as 1/3 of patients receiving vigabatrin therapy have VFDs.
Zbrani podatki iz raziskav o prevalenci kažejo, da ima izpade vidnega polja kar 1/3 bolnikov,
This medicinal product is not intended for use in women of child-bearing potential.
To zdravilo ni namenjeno uporabi pri ženskah v rodni dobi.
Hepatobiliar y disorders hepatitis
Bolezni jeter, žolčnika in žolčevodov hepatitis
Available data suggests that visual field defects are irreversible even after discontinuation of vigabatrin.
Razpoložljivi podatki kažejo, da so izpadi vidnega polja celo po prekinitvi zdravljenja z vigabatrinom ireverzibilni.
General disorders and fatigue oedema, irritability administratio n site conditions
Splošne težave in spremembe na mestu aplikacije utrujenost edem, razdražljivost
Kigabeq 100 mg is supplied in packs of 100 soluble tablets.
Zdravilo Kigabeq 100 mg je dobavljeno v paketih s po 100 tabletami za peroralno raztopino.
Movement disorders either alone or in association with abnormalities in MRI have been reported in patients treated with vigabatrin for infantile spasms but their frequency is not known.
Pri bolnikih, zdravljenih z vigabatrinom zaradi infantilnih spazmov, so samostojno ali v povezavi z nepravilnostmi pri slikanju z magnetno resonanco opazili motnje gibanja, vendar njihova pogostnost ni znana.
However, in rabbits, a slight increase in the incidence of cleft palate at doses of 150-200 mg/kg was seen.
Vendar so pri kuncih, ki so prejemali odmerke 150-200 mg/kg, opazili rahlo povečanje pojavnosti razcepljenega neba.
Kigabeq 500 mg is supplied in packs of 50 soluble tablets
Zdravilo Kigabeq 500 mg je dobavljeno v paketih s po 50 tabletami za peroralno raztopino.
Kigabeq is to be given by mouth and may be taken before or after meals.
Zdravilo Kigabeq se daje peroralno in ga je mogoče jemati pred obroki ali po njih.
Half a tablet (500 mg) or two and a half tablets (100 mg)
pol tablete (500 mg) ali dve tableti in pol (100 mg)
In the brain, microvacuolation due to intramyelinic oedema has been observed in white matter tracts of rat, mouse and dog at doses of 30-50 mg/kg/day.
Pri odmerkih 30-50 mg/kg/dan so v traktu bele snovi podgan, miši in psov opazili mikrovakuolacijo zaradi intramielinskega edema.
Psychiatric events (e.g., agitation, depression, abnormal thinking, paranoid reactions) have been reported during vigabatrin treatment.
Med zdravljenjem z vigabatrinom so poročali o psihiatričnih dogodkih (npr. vznemirjenju, depresiji, neobičajnem razmišljanju, paranoidnih reakcijah).
encephalo pathy optic neuritis brain MRI abnormalities.
encefalop atija optični nevritis nepravilnosti možganov pri slikanju z magnetno resonanco, motnje gibanja,
What Kigabeq looks like and contents of the pack Kigabeq are white oval scored soluble tablets.
Zdravilo Kigabeq je v obliki belih ovalnih tablet z zarezo za peroralno raztopino.
Such changes have not been seen in vigabatrin treated patients without a VFD.
Takšnih sprememb pri bolnikih, ki so bili zdravljeni z vigabatrinom in niso imeli izpadov vidnega polja, ni mogoče opaziti.
One tablet (500 mg) and two tablets (100 mg)
ena tableta (500 mg) in dve tableti (100 mg)
Psychiatric disorders agitation, aggression, nervousness, depression, paranoid reaction hypomania, mania, psychotic disorder suicide attempt hallucination
depresija, paranoidna reakcija hipomanija, manija,
After administration of a single 37-50 mg/kg dose of an oral solution vigabatrin tmax was approximately 2.5 hours in neonates and infants, and 1 hour in children.
Po dajanju enojnega odmerka peroralne raztopine vigabatrina 37-50 mg/kg je tmax znašal približno
Fill a drinking glass with one or two teaspoons of water (approximately 5 or 10 ml), according to the age of the child. Add the prescribed number of Kigabeq tablets or tablet halves to the water.
Napolnite kozarec z eno ali dvema čajnima žličkama vode (približno 5 ali 10 ml) glede na starost otroka.
Gastrointesti nal disorders nausea, vomiting, abdominal pain
Bolezni prebavil navzea, bruhanje,
Vigabatrin should be used with caution in patients with a history of psychosis, depression or behavioural problems.
Pri bolnikih z anamnezo psihoze, depresije ali vedenjskih težav je treba vigabatrin uporabljati previdno.
Each soluble tablet contains 500 mg vigabatrin.
Ena tableta za peroralno raztopino vsebuje 500 mg vigabatrina.
Kigabeq 100 mg soluble tablets Kigabeq 500 mg soluble tablets
Kigabeq 100 mg tablete za peroralno raztopino Kigabeq 500 mg tablete za peroralno raztopino
Number of tablets (strength) Evening
Število tablet (jakost)
Contact the doctor if your child has these psychological effects nausea (feeling sick), vomiting and abdominal pain blurred vision, double vision and uncontrolled movement of the eye, which may cause dizziness speech disorder decrease in the number of red blood cells (anaemia)
Če so se pri vašem otroku pojavili ti psihološki učinki, se posvetujte z otrokovim zdravnikom; navzea (občutek slabosti), bruhanje in bolečine v trebuhu; zamegljen vid, dvojni vid in nenadzorovano gibanje oči, ki lahko povzroča omotičnost;
Always give this medicine to your child exactly as the doctor has told you.
Pri dajanju tega zdravila svojemu otroku natančno upoštevajte navodila zdravnika.
If your child gets any side effects, talk to your child's doctor or pharmacist.
Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z njegovim zdravnikom ali farmacevtom.
What you need to know before your child takes Kigabeq
Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Kigabeq Ne dajajte zdravila Kigabeq:
A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Majhno povečano tveganja za samomorilne misli in vedenje je bilo dokazano tudi z metaanalizo randomiziranih, s placebom nadzorovanih preskušanj zdravil proti epilepsiji.
Vigabatrin overdose has been reported.
Poročali so o prevelikem odmerjanju vigabatrina.
Movement disorders including dystonia, dyskinesia and hypertonia, have been reported in patients treated with vigabatrin for infantile spasms.
Pri bolnikih, zdravljenih z vigabatrinom zaradi infantilnih spazmov, so poročali o motnjah gibanja, vključno z distonijo, diskinezijo in hipertonijo.
Each soluble tablet contains 100 mg vigabatrin.
Ena tableta za peroralno raztopino vsebuje 100 mg vigabatrina.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Pri bolnikih, ki so bili zdravljeni z zdravili proti epilepsiji za več indikacij, so poročali o samomorilnih mislih in vedenju.
Pregnancy and breast-feeding This medicine is not intended for use in women of child-bearing potential or in breast-feeding women.
To zdravilo ni namenjeno uporabi pri ženskah v rodni dobi ali ženskam, ki dojijo.
0.5 to 1 g/day
od 10 do 15 kg: od 0,5 do 1 g/dan od 15 do 30 kg: od 1 do 1,5 g/dan
Epidemiology of VFD in patients with refractory partial epilepsy was observed in an observational, open-label, multicentre, comparative, parallel group, Phase IV study, including 734 patients, at least 8 years old, with refractory partial epilepsy for at least one year.
734 bolnikov, starih vsaj 8 let, pri katerih je bila refraktarna delna epilepsija prisotna vsaj eno leto, so ugotovili epidemiologijo izpadov vidnega polja pri bolnikih z refraktarno delno epilepsijo.
If your child develops symptoms like sleepiness, reduced consciousness and movements (stupor) or confusion, tell your child's doctor who may reduce the dose or stop Kigabeq treatment.
(omamljenost) ali zmedenost, to povejte njegovemu zdravniku, ki lahko zmanjša odmerek ali zdravljenje z zdravilom Kigabeq ustavi.
Uncommon side effects (may affect up to 1 in 100 people) lack of coordination or fumbling more severe psychological problems such as feeling elated or over-excited, which causes unusual behaviour, and feeling detached from reality skin rash
več resnih psiholoških težav, kot je občutek vzhičenosti ali prevelike vznemirjenosti, ki povzroča nenavadno vedenje, in občutek ločenosti od resničnosti; kožni izpuščaj.
500 mg tablet size: 16.0 mm x 9.0 mm
500 mg, velikost tablete: 16,0 mm x 9,0 mm 100 mg, velikost tablete: 9,4 mm x 5,3 mm
Proposed doses for second titration step (100 mg/kg/day) (Day 6)
(100 mg/kg/dan) (6. dan)
Kigabeq 100 mg soluble tablets EU/1/18/1302/001
EU/1/18/1302/001 100 tablet za peroralno raztopino - 100 mg EU/1/18/1302/002 50 tablet za peroralno raztopino - 500 mg
Pack size: 50 soluble tablets.
Velikost pakiranja: 50 tablet za peroralno raztopino
One tablet (500 mg)
ena tableta (500 mg)
Pack size: 100 soluble tablets.
Velikost pakiranja: 100 tablet za peroralno raztopino
Kigabeq is for oral or gastric use and may be taken before or after meals.
Zdravilo Kigabeq se daje peroralno ali prek gastrične sonde in ga je mogoče jemati pred obroki ali po njih.
Your child should not ride a bicycle, climb or take part in hazardous activity if the child has symptoms like drowsiness or dizziness with Kigabeq.
Če so se pri vašem otroku zaradi zdravila Kigabeq pojavili simptomi, kot je zaspanost ali omotica, ne sme kolesariti, plezati ali sodelovati pri nevarnih dejavnostih.
Dissolution of soluble tablet
Raztapljanje tablete za peroralno raztopino
Two tablets (100 mg)
dve tableti (100 mg)
One tablet (100 mg)
ena tableta (100 mg)
Three tablets (100 mg)
tri tablete (100 mg)
Soluble tablet
Tableta za peroralno raztopino
Asymptomatic and transient Magnetic Resonance Imaging (MRI) abnormalities in the brain have been observed in some infants treated with vigabatrin for infantile spasms.
motnje gibanja in nepravilnosti na slikah možganov, slikanih z magnetno resonanco, pri majhnih dojenčkih, zdravljenih zaradi infantilnih spazmov.
Half a tablet (500 mg)
pol tablete (500 mg)
Psychiatric disorders
Pediatrična populacija Psihiatrične motnje
Gastric administration should be used for children who cannot swallow, but can be fed by enteral route.
Pri otrocih, ki ne morejo požirati, mogoče pa jih je hraniti enteralno, je treba zdravilo dati prek gastrične sonde.
Proposed doses for first titration step (75 mg/kg/day) (Day 3)
(75 mg/kg/dan) (3. dan)
Crospovidone type B Mannitol
- Druge sestavine so krospovidon tip B, manitol, natrijev stearilfumarat.
Four tablets (100 mg)
štiri tablete (100 mg)
NAME OF THE MEDICINAL PRODUCT Kigabeq 500 mg soluble tablets vigabatrin
Kigabeq 500 mg tablete za peroralno raztopino vigabatrin
Kigabeq 100 mg soluble tablets For children aged 1 month to less than 7 years
Zdravilo Kigabeq je indicirano za zdravljenje dojenčkov in otrok, starih od 1 meseca do manj kot 7 let,
1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
1 x 500-mg tableta zjutraj 1 x 500-mg in 1 x 100-mg tableta zvečer
The recommended starting dose is 50 mg/kg/day.
Monoterapija za infantilne spazme (Westov sindrom) Priporočeni začetni odmerek je 50 mg/kg/dan.
One tablet (500 mg) and one tablet (100 mg)
ena tableta (500 mg) in ena tableta (100 mg)
Kigabeq 500 mg soluble tablets
Kigabeq 500 mg tablete za peroralno raztopino
Two and a half tablets (100 mg)
dve tableti in pol (100 mg)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 100 SOLUBLE TABLETS OF KIGABEQ 100 MG
ŠKATLA, KI VSEBUJE 1 PLASTENKO S 100 TABLETAMI ZA PERORALNO RAZTOPINO ZDRAVILA KIGABEQ 100 MG
Pregnancy
Otroci
Ask your child's doctor to show you how to give this medicine.
O tem, kako dajati to zdravilo, vprašajte otrokovega zdravnika.
One and a half tablets (500 mg)
ena tableta in pol (500 mg)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 50 SOLUBLE TABLETS OF KIGABEQ 500 MG
ŠKATLA, KI VSEBUJE 1 PLASTENKO S 50 TABLETAMI ZA PERORALNO RAZTOPINO ZDRAVILA KIGABEQ 500 MG
1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
1 x 500-mg in 1 x 100-mg tableta zvečer 1 x 500-mg in 1 x 100-mg tableta zjutraj 1 x 500-mg in 1 x 100-mg tableta zvečer
Four and a half tablets (100 mg)
štiri tablete in pol (100 mg)
Three and a half tablets (100 mg)
tri tablete in pol (100 mg)
Breastfeeding
vigabatrin
One and a half tablets (100 mg)
ena tableta in pol (100 mg)
Kigabeq 100 mg soluble tablets
Navodilo za uporabo Kigabeq 100 mg tablete za peroralno raztopino
Half a tablet (100 mg)
zvečer pol tablete (100 mg)
It is important that you tell the doctor promptly if there is any change in your child's vision.
Pomembno je, da zdravniku takoj poveste,
Check with the doctor or pharmacist if you are not sure.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Hepatic impairment
bolečine v trebuhu
One soluble tablet of Kigabeq 100 mg contains 100 mg vigabatrin One soluble tablet of Kigabeq 500 mg contains 500 mg vigabatrin - The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate
Kigabeq 500 mg tablete za peroralno raztopino Ena tableta za peroralno raztopino vsebuje 500 mg vigabatrina.
NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin
Kigabeq 100 mg tablete za peroralno raztopino vigabatrin
Very common side effects (may affect more than 1 in 10 people) excitation or restlessness tiredness and pronounced sleepiness joint pain
Drugi neželeni učinki so: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
The recommended starting dose is 40 mg/kg/day.
Rezistentna delna epilepsija (napadi žariščnega izvora) Priporočeni začetni odmerek je 40 mg/kg/dan.
Other side effects include:
UPORABNO DO:
PHARMACEUTICAL FORM AND CONTENTS 50 soluble tablets
50 tablet za peroralno raztopino
Adolescents and adults (>12 years old)
Mladostniki in odrasli (stari > 12 let) Skupina I 1 Skupina II 2 Skupina III Skupina I 3 Skupina II 4 Skupina III
PHARMACEUTICAL FORM AND CONTENTS 100 soluble tablets
100 tablet za peroralno raztopino
The recommended dose is one tablet twice a day (every 12 hours) for 10 days.
Priporočeni odmerek je ena tableta dvakrat na dan (vsakih 12 ur) 10 dni
It is available as tablets (200 mg).
Na voljo je v obliki tablet (200 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011.
Evropska komisija je dovoljenje za promet z zdravilom Dificlir, veljavno po vsej Evropski uniji, odobrila dne 5. decembra 2011.
The main measure of effectiveness was the number of patients that were cured after 10 days of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba ozdravljena po 10 dneh zdravljenja.
The full EPAR for Dificlir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dificlir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people.
C. difficile so bakterije, ki so naravno prisotne v črevesju in zdravim osebam ne povzročajo nikakršnih težav.
However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut.
Vendar pa lahko nekateri antibiotiki, ki se uporabljajo za zdravljenje okužb, porušijo ravnovesje „dobrih“ bakterij v črevesju.
The effects of Dificlir were first tested in experimental models before being studied in humans.
Učinki zdravila Dificlir so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Dificlir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Other information about Dificlir
Druge informacije o zdravilu Dificlir
When looking at the results of the two studies, 92 % of patients on Dificlir were cured compared with 90% of patients on vancomycin.
Ob primerjavi izsledkov dveh študij je bilo z zdravilom Dificlir ozdravljenih 92 % bolnikov, z vankomicinom pa 90 %.
When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever.
Ko pride do tega, se lahko bakterije C. difficile razmnožijo in proizvajajo toksine (strupe), ki povzročajo bolezni, kot sta driska in povišana temperatura.
The CHMP noted however, that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended that further studies in this group should be carried out.
Vendar CHMP ugotavlja, da obstajajo negotovosti glede učinkov zdravila Dificlir pri nekaterih skupinah bolnikov, na primer tistih, ki imajo težave z jetri in ledvicami, ter priporoča, da se v tej skupini izvedejo nadaljnje študije.
EPAR summary for the public fidaxomicin
Povzetek EPAR za javnost fidaksomicin
This is a summary of the European public assessment report (EPAR) for Dificlir.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dificlir.