natgillin/translations-raw huggingface dataset:
In addition, the PRAC recommended changes to the educational materials for the oral retinoids (acitretin, alitretinoin and isotretinoin) to ensure healthcare professionals and patients are informed about the risks associated with oral retinoids (acitretin, alitretinoin and isotretinoin) in pregnant women and women of child-bearing potential and on the measures necessary to minimise the risk.
Poleg tega je odbor PRAC priporočil spremembe izobraževalnih gradiv za peroralne retinoide (acitretin, alitretinoin in izotretinoin), da se zagotovi obveščenost zdravstvenih delavcev in bolnikov o tveganjih, povezanih s peroralnimi retinoidi
The PRAC therefore recommended that the use of topical retinoids should be contraindicated during pregnancy and in women planning a pregnancy given the non-life threatening nature of the indications.
Odbor PRAC zato priporoča, da je treba uporabo lokalnih retinoidov med nosečnostjo in pri ženskah, ki načrtujejo nosečnost,
The daily dose is divided into two halves, taken morning and evening about 12 hours apart.
Dnevni odmerek je razdeljen na dve polovici, ki se vzameta zjutraj in zvečer v razmiku približno 12 ur.
The European Medicines Agency decided that Inovelon's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Inovelon večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Inovelon?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inovelon?
Inovelon received a marketing authorisation valid throughout the EU on 16 January 2007.
Za zdravilo Inovelon je bilo 16. januarja 2007 izdano dovoljenje za promet, veljavno po vsej EU.
The dose is then adjusted every other day according to the patient's response to treatment.
Ta odmerek se nato glede na odziv bolnika na zdravljenje vsak drugi dan prilagodi.
Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Lennox-Gastautov sindrom je ena od najtežjih oblik epilepsije pri otrocih.
As for all medicines, data on the use of Inovelon are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Inovelon stalno spremljajo.
Further information on Inovelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Inovelon so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In older patients, treatment usually starts with a dose of 200 or 400 mg daily.
Pri starejših bolnikih se zdravljenje običajno začne z dnevnim odmerkom 200 mg ali 400 mg.
Given that the disease behaves the same way in both age groups, Inovelon could therefore be expected to act similarly in children aged 1 to 4 years.
Ker bolezen poteka enako v obeh starostnih skupinah, bi bilo zato mogoče za zdravilo Inovelon pričakovati, da bo delovalo podobno pri otrocih, starih od enega do štirih let.
Inovelon should be taken with water and food.
Zdravilo Inovelon je treba zaužiti skupaj z vodo in hrano.
By attaching to the channels, rufinamide prevents them switching from an inactive state to an active state.
Ko se rufinamid veže nanje, jim prepreči, da bi prešli iz nedejavnega v dejavno stanje.
Treatment in children less than 4 years of age generally starts with a daily dose of 10 mg per kilogram body weight.
Zdravljenje otrok, mlajših od štirih let, se na splošno začne z dnevnim odmerkom 10 mg na kilogram telesne mase.
Other information about Inovelon
Druge informacije o zdravilu Inovelon
The company also presented the results of a study showing that the oral suspension produced the same levels of the active substance in the blood as the tablets.
Družba je predložila tudi rezultate študije, iz katerih je razvidno, da je peroralna suspenzija v krvi proizvedla enake ravni zdravilne učinkovine kot tablete.
A study involving 37 children aged 1 to 4 years was inconclusive because of its small size and because it was not designed to show benefit.
Rezultati študije, v katero je bilo vključenih 37 otrok, starih od enega do štirih let, so bili nezanesljivi, ker je bila premajhna in ni bila zasnovana za prikaz koristi.
This dampens down the activity of the brain cells and prevents abnormal electrical activity from spreading through the brain.
To zavira delovanje možganskih celic in prepreči širjenje nenormalne električne dejavnosti po možganih.
The most common side effects with Inovelon (seen in more than 1 in 10 patients) are sleepiness, headache, dizziness, vomiting, and tiredness.
Najpogostejši neželeni učinki zdravila Inovelon (opaženi pri več kot 1 bolniku od 10) so zaspanost, glavobol, vrtoglavica, bruhanje in utrujenost.
Side effects reported with Inovelon are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Inovelon, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inovelon have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Inovelon upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Inovelon?
Kakšna tveganja so povezana z zdravilom Inovelon?
An overview of Inovelon and why it is authorised in the EU
Pregled zdravila Inovelon in zakaj je odobreno v EU
All of the patients had Lennox-Gastaut syndrome that was not controlled despite continuous treatment for at least four weeks with up to three other anti-epileptic medicines.
Vsi bolniki so imeli Lennox-Gastautov sindrom, ki ga kljub neprekinjenemu najmanj štiritedenskemu zdravljenju z do tremi drugimi zdravili za zdravljenje epilepsije ni bilo mogoče obvladati.
Why is Inovelon authorised in the EU?
Zakaj je bilo zdravilo Inovelon odobreno v EU?
This reduces the likelihood of a seizure occurring.
S tem se zmanjša verjetnost nastopa epileptičnega napada.
In a main study involving 139 patients aged between 4 and 30 years (three quarters of them below 17 years old) Inovelon caused a reduction in the number and severity of seizures.
V glavni študiji, v katero je bilo vključenih 139 bolnikov, starih od štiri do 30 let (tri četrtine so bile mlajše od 17 let), je zdravilo Inovelon zmanjšalo število in resnost epileptičnih napadov.
For more information about using Inovelon, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Inovelon glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
However, other analyses showed that doses based on body weight in children aged 1 to 4 years produced similar levels of the medicine in the body to those seen with standard doses in older patients.
Vendar pa so druge analize pokazale, da odmerki na podlagi telesne mase pri otrocih od enega do štirih let starosti proizvedejo podobne ravni zdravila v telesu kot običajni odmerki pri starejših bolnikih.
Lennox-Gastaut syndrome is rare, and Inovelon was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Lennox-Gastautov sindrom je redek, zato je bilo zdravilo Inovelon 20. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The main measures of effectiveness were the change in the number of seizures in the four weeks after Inovelon or placebo was added, compared with the four weeks before it was added, as well as the change in severity of seizures assessed on a 7-point scale by the patient's parent or guardian.
Glavni merili učinkovitosti sta bili sprememba števila napadov v štirih tednih po dodajanju zdravila Inovelon ali placeba v primerjavi s štirimi tedni pred njunim dodajanjem ter sprememba resnosti napadov, ki so jo ocenili bolnikovi starši ali skrbniki na podlagi lestvice od 1 do 7.
What is Inovelon and what is it used for?
Kaj je zdravilo Inovelon in za kaj se uporablja?
The active substance in Inovelon, rufinamide, acts by attaching to special channels (sodium channels) on brain cells that control their electrical activity.
Zdravilna učinkovina v zdravilu Inovelon, rufinamid, deluje tako, da se veže na posebne kanalčke na površini možganskih celic (natrijeve kanalčke), ki nadzirajo električno delovanje celic.
Inovelon is an epilepsy medicine used to treat patients aged one year or older who have LennoxGastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood.
Inovelon je zdravilo, ki se uporablja za zdravljenje epilepsije pri bolnikih, starejših od enega leta, z Lennox-Gastautovim sindromom, tj. redko obliko epilepsije, ki navadno prizadene otroke, a se lahko nadaljuje tudi v odraslem obdobju.
The medicine should not be used in patients who have severe problems with their liver.
Zdravila Inovelon ne smejo jemati bolniki s hudimi težavami z jetri.
Its symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Simptomi tega sindroma so različne vrste epileptičnih napadov, nenormalna električna dejavnost možganov, nezmožnost učenja in vedenjske težave.
Patients taking Inovelon had a 35.8% reduction in the total number of seizures, falling from an average of 290 seizures in the four-week period before Inovelon was started.
Pri bolnikih, ki so jemali zdravilo Inovelon, se je število vseh napadov zmanjšalo za 35,8 % od povprečno 290 napadov v štirih tednih pred začetkom jemanja zdravila Inovelon.
Patients adding Inovelon also had a 42.5% reduction in the number of ‘tonic-atonic' seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared with a 1.9% increase in those adding placebo.
Pri bolnikih, ki so dodajali zdravilo Inovelon, so opazili tudi zmanjšanje števila tonično-atoničnih napadov (vrste napadov, ki so običajno prisotni pri bolnikih z Lennox-Gastautovim sindromom, pri katerih bolnik pogosto pade na tla) za 42,5 %, v primerjavi z 1,9-odstotnim povečanjem pri tistih, ki so kot dodatek jemali placebo.
Inovelon contains the active substance rufinamide.
Zdravilo Inovelon vsebuje zdravilno učinkovino rufinamid.
What benefits of Inovelon have been shown in studies?
Kakšne koristi je zdravilo Inovelon izkazalo med študijami?
Inovelon is used as an add-on to other anti-epileptic medicines.
Zdravilo Inovelon se uporablja kot dodatek zdravljenju z drugimi zdravili za preprečevanje epileptičnih napadov.
Inovelon must not be used in patients who are hypersensitive (allergic) to rufinamide, triazole derivatives (such as some medicines used to treat fungal infections) or any of the other ingredients.
Zdravilo Inovelon se ne sme uporabljati pri bolnikih, ki utegnejo biti preobčutljivi za (alergični na) rufinamid, derivate triazola (kot so nekatera zdravila za zdravljenje glivičnih okužb) ali katero koli drugo sestavino zdravila.
The dose of Inovelon depends on the patient's age and weight and whether the patient is also taking valproate (another anti-epileptic medicine).
Odmerek zdravila Inovelon je odvisen od starosti in telesne mase bolnika ter tega, ali bolnik jemlje tudi valproat (drugo zdravilo za zdravljenje epilepsije).
The study compared the effects of adding Inovelon tablets or adding placebo (a dummy treatment) to the other medicines the patients were taking.
V študiji so primerjali učinke dodajanja tablet zdravila Inovelon ali dodajanja placeba (zdravila brez zdravilne učinkovine) k drugim zdravilom, ki so jih jemali bolniki.
An improvement in the severity of seizures was reported for about half of the patients adding Inovelon, compared with a third of those adding placebo.
O zmanjšanju resnosti napadov so poročali pri približno polovici bolnikov, ki so kot dodatno zdravilo prejemali Inovelon, v primerjavi s tretjino tistih, ki so kot dodatno zdravilo prejemali placebo.
For the full list of side effects of Inovelon, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Inovelon glejte navodilo za uporabo.
Inovelon can only be obtained with a prescription and treatment should be started by a paediatrician (a doctor specialised in treating children) or a neurologist (a doctor who treats brain disorders) experienced in the treatment of epilepsy.
Predpisovanje in izdaja zdravila Inovelon je le na recept, zdravljenje pa mora začeti pediater (zdravnik, ki je specializiran za zdravljenje otrok) ali nevrolog (zdravnik, ki zdravi možganske bolezni).
How is Inovelon used?
Kako se zdravilo Inovelon uporablja?
There was a 1.6% reduction in the patients who added placebo to their existing treatment.
Pri bolnikih, ki so kot pomožno zdravilo prejemali placebo, so opazili 1,6-odstotno zmanjšanje števila napadov.
Its terminal half-life is about one day.
Njegova končna razpolovna doba je približno en dan.
In case of diarrhoea, make sure that you drink enough water.
V primeru driske poskrbite, da popijete dovolj vode.
Steady-state is reached within three to four days.
Stabilno stanje se doseže v treh do štirih dneh.
The absolute oral bioavailability is >90%.
Absolutna biološka uporabnost je > 90 %.
This effect is too small to be clinically relevant.
Ta učinek je prešibek, da bi bil klinično pomemben.
Non-renal elimination contributes to about 35% of total elimination.
Neledvično izločanje prispeva k okoli 35 % skupnega izločanja.
- Tell your doctor if you are pregnant or planning to become pregnant.
- Obvestite svojega zdravnika, če ste noseči ali načrtujete zanositev.
This effect can be attributed to a diminished renal function in older people.
Ta učinek je mogoče pripisati zmanjšani ledvični funkciji pri starejših.
Date of first authorisation: 15 October 2009 Date of latest renewal: 06 June 2014
Datum prve odobritve: 15. oktober 2009 Datum zadnjega podaljšanja: 06. junij 2014
The mechanism for this interaction is not clear.
Mehanizem tega medsebojnega delovanja ni znan.
Long-term study
Dolgotrajna študija
Decreased appetite
Pogosti zmanjšan apetit
Overall, the safety profile of Resolor in children was the same as in adults.
Na splošno je bil varnostni profil zdravila Resolor pri otrocih enak kot pri odraslih.
The doctor may want to reassess your condition and the benefit of continued treatment after the first 4 weeks and thereafter at regular intervals.
Zdravnik bo morda hotel ponovno oceniti vaše stanje in koristi nadaljnjega zdravljenja po prvih štirih tednih in nato v rednih razmikih.
Just take your next dose at the usual time.
Preprosto nadaljujte z naslednjim odmerkom ob običajnem času.
It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel.
Deluje na mišično steno črevesa in pomaga ponovno vzpostaviti normalno delovanje črevesa.
What Resolor is and what it is used for
Kaj je zdravilo Resolor in za kaj ga uporabljamo
- Intestinal perforation or obstruction due to structural or functional disorder of the gut wall,
- Perforacija ali obstrukcija črevesa zaradi strukturne ali funkcijske okvare črevesne stene,
As with any new symptom, patients should discuss the new onset of palpitations with their physician.
Kot pri vseh novih simptomih se morajo bolniki o novem pojavu palpitacij pogovoriti s svojim zdravnikom.
Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney disease.
Vaš zdravnik lahko priporoči tudi nižji odmerek od ene 1 mg tablete na dan, če imate hudo ledvično bolezen.
Unchanged active substance made up about 92-94% of the total radioactivity in plasma.
Nespremenjena zdravilna učinkovina je predstavljala okoli 92-94 % celotne radioaktivnosti v plazmi.
If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered.
Če vnos prukaloprida enkrat na dan ni učinkovit po 4 tednih zdravljenja, je treba bolnika ponovno pregledati in pretehtati koristi nadaljnjega zdravljenja.
Pharmacotherapeutic group: Other drugs for constipation, ATC code: A06AX05.
Farmakoterapevtska skupina: druga zdravila proti zaprtju, oznaka ATC: A06AX05.
R107504, R084536 and R104065 (formed by O-demethylation) were identified as minor plasma metabolites.
R107504, R084536 in R104065 (ki nastanejo z O-demetilacijo) so bili opredeljeni kot manjši presnovki v plazmi.
However, sometimes Resolor may cause dizziness and tiredness, especially on the first day of treatment, and this may have an effect on driving and use of machines.
Vendar pa lahko včasih zdravilo Resolor povzroči vrtoglavico in utrujenost, predvsem prvi dan zdravljenja, to pa lahko vpliva na sposobnost upravljanja vozil in strojev.
In case of prolonged treatment, the benefit should be reassessed at regular intervals.
V primeru dolgotrajnega zdravljenja je treba v rednih razmikih oceniti koristi.
The clinical significance or benefit of this mechanism of action when compared with other laxatives has not been investigated.
Klinične pomembnosti ali koristi tega mehanizma delovanja v primerjavi z drugimi odvajali niso raziskali.
If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
Če imate zelo hudo diarejo, kontracepcijske tablete morda ne delujejo ustrezno in je priporočena uporaba dodatne kontracepcijske metode.
The usual dose of Resolor for most patients is one 2 mg tablet once a day.
Običajni odmerek zdravila Resolor za večino bolnikov je ena 2 mg tableta enkrat na dan.
Fertility Animal studies indicate that there is no effect on male or female fertility.
Študije na živalih kažejo, da ni vpliva na plodnost moških ali žensk.
The study is therefore considered to be inconclusive with respect to efficacy.
Zato menijo, da iz te študije ni mogoče sklepati o učinkovitosti.
Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Zaradi velike izgube tekočine zaradi diareje ali bruhanja je morda potreben popravek elektrolitskih motenj.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z njim.
Resolor with food and drink Resolor can be taken with or without food and drinks, at any time of the day.
Zdravilo Resolor skupaj s hrano in pijačo Zdravilo Resolor lahko vzamete s hrano in pijačo ali brez nje ob katerem koli času dneva.
See the instructions in the patient leaflet of the contraceptive pill you are taking.
Preberite navodila za uporabo kontracepcijskih tablet, ki jih uporabljate.
Manufacturer Sanico NV Veedijk 59
Izdelovalec Sanico NV Veedijk 59
Paediatric population: Resolor should not be used in children and adolescents younger than 18 years (see section 5.1).
Pediatrična populacija: zdravilo Resolor se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 5.1).
The accumulation ratio after once daily dosing ranged from 1.9 to 2.3.
Kopičenje po enkratnem dnevnem odmerku je segalo od 1,9 do 2,3.
Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy.
Zaradi specifičnega načina delovanja prukaloprida (stimulacija propulzivne motilitete) se ne pričakuje, da bo povečanje dnevnega odmerka 2 mg povečalo učinkovitost.
Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to prucalopride is unknown.
Med kliničnimi študijami so bili opaženi primeri spontanega splava, čeprav ob sočasni prisotnosti drugih dejavnikov tveganja povezava s prukalopridom ni znana.
Prucalopride has a low pharmacokinetic interaction potential.
Prukaloprid ima nizek farmakokinetični interakcijski potencial.
Although prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations.
Čeprav je prukaloprid lahko šibek substrat za P-glikoprotein (P-gp), ni zaviralec P-gp v klinično pomembnih koncentracijah.
Take Resolor every day for as long as your doctor prescribes it.
Zdravilo Resolor jemljite vsak dan toliko časa, kot vam je predpisal vaš zdravnik.
In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
V primeru hude diareje se lahko učinkovitost peroralnih kontraceptivov zmanjša in se priporoča uporaba dodatne kontracepcijske metode, da bi preprečili morebitno neučinkovitost peroralne kontracepcije (glejte informacije, priložene peroralnemu kontraceptivu).
Renal excretion is the main route of elimination of prucalopride (see section 5.2).
Ledvično izločanje je glavni način izločanja prukaloprida (glejte poglavje 5.2).
The majority of patients continued using prucalopride.
Večina bolnikov je nadaljevala z uporabo prukaloprida.
What you need to know before you take Resolor
Kaj morate vedeti, preden boste vzeli zdravilo Resolor
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (including pregnancy, embryonal/foetal development, parturition or postnatal development) (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na toksičnost za razmnoževanje (vključno z nosečnostjo, razvojem zarodka/plodu, porodom ali postnatalnim razvojem) (glejte poglavje 5.3).
Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine.
Interakcije podobnega obsega lahko pričakujemo pri drugih močnih zaviralcih P-gp, kot so verapamil, ciklosporin A in kinidin.
In the absence of human data in women who actively breast-fed while taking Resolor, a decision should be made whether to discontinue breast-feeding or to discontinue Resolor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Zaradi pomanjkanja podatkov pri ljudeh pri ženskah, ki med uporabo zdravila Resolor aktivno dojijo, se je treba odločiti med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Resolor, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Renal excretion of unchanged prucalopride involves both passive filtration and active secretion.
Ledvično izločanje nespremenjenega prukaloprida vključuje pasivno filtracijo in aktivni izloček.
If you are older than 65 years or have severe liver disease, the starting dose is one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if needed.
Če ste starejši od 65 let ali imate hudo jetrno bolezen, je začetni odmerek ena 1 mg tableta enkrat na dan, ki ga lahko vaš zdravnik po potrebi poviša na 2 mg enkrat na dan.
If you have taken more Resolor than you should, it is possible that you will get diarrhoea, headache and/or nausea.
Če ste vzeli več zdravila Resolor, kot bi smeli, boste morda dobili drisko, glavobol in/ali vam bo slabo.
If you stop taking Resolor If you stop taking Resolor, your constipation symptoms may come back again.
Če ste prenehali jemati zdravilo Resolor Če ste prenehali jemati zdravilo Resolor, se lahko ponovno pojavijo simptomi zaprtja.
Other adverse reactions have been reported occasionally.
Občasno se poroča o drugih neželenih učinkih.
Posology Adults: 2 mg once daily with or without food, at any time of day.
Odmerjanje Odrasli: 2 mg enkrat na dan, s hrano ali brez nje, ob katerem koli času dneva.
Tremors, migraine
Občasni tremor, migrena
Resolor has been shown not to cause rebound phenomena, nor to induce dependency.
Pokazalo se je, da zdravilo Resolor ne povzroča povratnega fenomena ali odvisnosti.