natgillin/translations-raw huggingface dataset:
Information on the use and licensing of California poppy medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, v državah članicah EU se obrnite na pristojni nacionalni organ.
Herbal medicines containing California poppy are usually available in solid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo zel kalifornijskega zlatega maka, so navadno na voljo v trdnih oblikah za peroralno jemanje (zaužitje skozi usta).
Detailed instruction on how to take California poppy medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo zel kalifornijskega zlatega maka, in o tem, kdo lahko ta zdravila jemlje, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
California poppy preparations are obtained by powdering the dried above-ground parts of the plant.
Pripravki iz zeli kalifornijskega zlatega maka se pridobivajo z drobljenem suhih nadzemnih delov rastline v prašek.
The HMPC conclusions on the use of California poppy medicines are based on their long-standing use.
Zaključki HMPC v zvezi z uporabo zdravil, ki vsebujejo zel kalifornijskega zlatega maka, zato temeljijo na njihovi dolgotrajni uporabi.
For more information about treatment with California poppy medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What evidence supports the use of California poppy medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel kalifornijskega zlatega maka?
What are the risks associated with California poppy medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo zel kalifornijskega zlatega maka?
What is California poppy?
Kaj je zel kalifornijskega zlatega maka?
Other information about California poppy medicines
Druge informacije o zdravilih, ki vsebujejo zel kalifornijskega zlatega maka
How are California poppy medicines approved in the EU?
Kako so zdravila, ki vsebujejo zel kalifornijskega zlatega maka, odobrena v EU?
For practical information about using California poppy medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
California poppy
Zel kalifornijskega zlatega maka
It should be taken consistently either with or without food.
Jemati ga je treba dosledno, bodisi s hrano bodisi brez nje.
Further information on Epidyolex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/epidyolex.
Nadaljnje informacije o zdravilu Epidyolex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/epidyolex.
This risk can be managed with restrictions and regular liver monitoring and is considered acceptable given the seriousness of the conditions and the lack of treatments.
To tveganje je mogoče obvladati z omejitvami in rednim spremljanjem delovanja jeter ter velja za sprejemljivo glede na resnost bolezni in pomanjkanje zdravljenj.
Further information on the orphan designations can be found on the European Medicines Agency's website: (Dravet syndrome: 15 October 2014; Lennox-Gastaut syndrome: 20 March 2017).
Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila: (Dravetov sindrom: 15. oktobra 2014; Lennox-Gastautov sindrom: 20. marca 2017).
The European Medicines Agency therefore decided that Epidyolex's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Epidyolex večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The recommended starting dose is 2.5 mg per kilogram body weight given twice a day.
Priporočeni začetni odmerek je 2,5 mg na kilogram telesne mase dvakrat dnevno.
What measures are being taken to ensure the safe and effective use of Epidyolex?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Epidyolex?
Regarding safety, treatment with Epidyolex is associated with an increased risk of liver problems.
Z vidika varnosti je zdravljenje z zdravilom Epidyolex povezano s povečanim tveganjem za težave z jetri.
After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice a day.
Po enem tednu je treba odmerek povečati do vzdrževalnega odmerka 5 mg/kg dvakrat dnevno.
Depending on the individual response and how well the medicine is tolerated, the doctor may increase the dose gradually up to a maximum of 10 mg/kg twice a day.
Glede na odziv posameznega bolnika in njegovo prenašanje zdravila lahko zdravnik odmerek postopoma povečuje do največjega odmerka 10 mg/kg dvakrat na dan.
The most common reason for stopping treatment was increased blood levels of liver enzymes (a sign of liver problems).
Najpogostejši razlog za prenehanje zdravljenja so povišane ravni jetrnih encimov v krvi (kar je lahko znak okvare jeter).
These conditions are rare, and Epidyolex was designated an ‘orphan medicine' (a medicine used in rare diseases).
Ti bolezni sta redki, zato je bilo zdravilo Epidyolex določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
As for all medicines, data on the use of Epidyolex are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Epidyolex stalno spremljajo.
Symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Med simptome spadajo različne vrste epileptičnih napadov, nenormalna električna dejavnost možganov, nezmožnost učenja in vedenjske težave.
As this is important for the transmission of electrical signals in some nerve cells, and seizures are caused by excessive electrical activity in the brain, altering the movement of calcium is expected to reduce or prevent the
Ker je to pomembno za prenos električnih signalov v nekaterih živčnih celicah in ker so epileptični napadi posledica prekomerne električne dejavnosti v možganih, se pričakuje, da se bodo s spremembo pretoka kalcija zmanjšali ali preprečili napadi pri bolnikih z Lennox-Gastautovim ali Dravetovim sindromom.
Side effects reported with Epidyolex are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Epidyolex, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Four studies involving 715 patients with Lennox-Gastaut or Dravet syndrome looked at the effect of Epidyolex when added to treatment with other epilepsy medicines.
V štirih študijah, v katerih je sodelovalo 715 bolnikov z Lennox-Gastautovim ali Dravetovim sindromom, so proučevali učinek zdravila Epidyolex kot dodatka k drugim zdravilom za zdravljenje epilepsije.
Doses are measured and given by mouth with a suitable syringe supplied with the medicine.
Odmerki se odmerijo in dajejo peroralno s primerno brizgo, priloženo zdravilu.
Epidyolex is available as a liquid containing 100 mg cannabidiol per ml.
Zdravilo Epidyolex je na voljo v obliki tekočine, ki vsebuje 100 mg kanabidiola na ml.
Epidyolex must not be used in patients whose blood levels of liver enzymes are more than three times the normal limit and who also have levels of bilirubin (another marker of liver problems) more than twice the normal limit.
Zdravila Epidyolex ne smejo uporabljati bolniki, ki imajo za več kot trikrat višje ravni jetrnih encimov v krvi od normalne vrednosti in katerih ravni bilirubina (drugega pokazatelja težav z jetri) so več kot dvakrat višje od normalne vrednosti.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Epidyolex 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 Epidyolex upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Cannabidiol is also thought to act on adenosine, a chemical messenger in the brain that plays an important role in suppressing seizures.
Kanabidiol naj bi deloval tudi na adenozin, kemični prenašalec v možganih, ki ima pomembno vlogo pri preprečevanju epileptičnih napadov.
Epidyolex can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of epilepsy.
Predpisovanje in izdaja zdravila Epidyolex je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem epilepsije.
Other information about Epidyolex
Druge informacije o zdravilu Epidyolex
For more information about using Epidyolex, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Epidyolex glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Epidyolex is a medicine used in addition to clobazam, another epilepsy medicine, to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome, rare types of epilepsy that begin in childhood and can continue into adulthood.
Epidyolex je zdravilo, ki se uporablja kot dodatek k klobazamu, drugemu zdravilu za zdravljenje epilepsije, pri bolnikih, starejših od dveh let, ki imajo Lennox-Gastautov sindrom (LGS) ali Dravetov sindrom, redki vrsti epilepsije, ki se začneta v otroštvu in se lahko nadaljujeta v odraslem obdobju.
An overview of Epidyolex and why it is authorised in the EU
Pregled zdravila Epidyolex in zakaj je odobreno v EU
Why is Epidyolex authorised in the EU?
Zakaj je bilo zdravilo Epidyolex odobreno v EU?
The main studies showed that Epidyolex is effective at lowering the number of seizures in patients with Lennox-Gastaut and Dravet syndromes who are taking clobazam.
Glavne študije so pokazale, da je zdravilo Epidyolex učinkovito pri zmanjševanju števila epileptičnih napadov pri bolnikih z Lennox-Gastautovim in Dravetovim sindromom, ki jemljejo klobazam.
What benefits of Epidyolex have been shown in studies?
Kakšne koristi zdravila Epidyolex so se pokazale v študijah?
The most common side effects with Epidyolex (which may affect more than 1 in 10 people) are somnolence (sleepiness), decreased appetite, diarrhoea, fever, tiredness and vomiting.
Najpogostejši neželeni učinki zdravila Epidyolex (ki se lahko pojavijo pri več kot 1 bolniku od 10) so somnolenca (zaspanost), zmanjšan tek, driska, povišana telesna temperatura, utrujenost in bruhanje.
For the full list of side effects of Epidyolex, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Epidyolex glejte navodilo za uporabo.
They showed that Epidyolex lowered the number of seizures after 14 weeks in patients who were also taking clobazam.
V njih je bilo dokazano, da je zdravilo Epidyolex po 14 tednih zmanjšalo število napadov pri bolnikih, ki so jemali tudi klobazam.
Although the way it works is not clearly understood, the active substance in Epidyolex, cannabidiol, is thought to act on targets that play a role in the movement of calcium in the cells.
Čeprav natančen način delovanja učinkovine v zdravilu Epidyolex, kanabidiola, še ni jasno razviden, naj bi ta delovala na prijemališča, ki imajo pomembno vlogo pri pretoku kalcija v celicah.
In the first two studies, patients with Lennox-Gastaut syndrome taking Epidyolex in combination with clobazam had a reduction of up to 64% in the number of drop seizures (brief loss of muscle tone and reduced consciousness, causing abrupt falls), compared with a reduction of up to 31% for patients given placebo (a dummy treatment) with clobazam.
V prvih dveh študijah so bolniki z Lennox-Gastautovim sindromom, ki so jemali zdravilo Epidyolex v kombinaciji s klobazamom, imeli do 64 % manj akinetičnih napadov (kratka izguba mišičnega tonusa in zmanjšana zavest, ki povzročita nenaden padec), v primerjavi z 31 -odstotnim znižanjem pri bolnikih, ki so prejemali placebo (zdravilo brez učinkovine) v kombinaciji s klobazamom.
What is Epidyolex and what is it used for?
Kaj je zdravilo Epidyolex in za kaj se uporablja?
What are the risks associated with Epidyolex?
Kakšna tveganja so povezana z zdravilom Epidyolex?
In the two other studies in patients with Dravet syndrome, the reduction in the number of convulsive seizures (major fits with loss of consciousness) was up to 61% for patients taking Epidyolex and clobazam, and up to 38% for patients on placebo and clobazam.
V drugih dveh študijah je bilo pri bolnikih z Dravetovim sindromom zmanjšanje števila konvulzivnih napadov (večjih napadov z izgubo zavesti) do 61 -odstotno pri bolnikih, ki so jemali zdravilo Epidyolex in klobazam, in do 38-odstotno pri tistih, ki so jemali placebo in klobazam.
Epidyolex contains the active substance cannabidiol.
Zdravilo Epidyolex vsebuje učinkovino kanabidiol.
How does Epidyolex work?
Kako zdravilo Epidyolex deluje?
How is Epidyolex used?
Kako se zdravilo Epidyolex uporablja?
180 (6 x 30) tablets (multipack)
180 (6 x 30) tablet
bottle (HDPE) (without outer carton)
800 mg Filmsko obložena tableta Peroralna uporaba Plastenka (HDPE) (brez zunanje škatle)
90 sachets (with dosing spoon)
90 vrečic (z odmerno žličko)
AUC and volume of distribution were in accordance with data from adults.
AUC in volumen distribucije sta bila skladna s podatki za odrasle.
From a microbiological point of view, the product should be used immediately.
Z mikrobiološkega vidika bi morala biti raztopina uporabljena takoj.
You may need further checks.
Mogoče boste potrebovali nadaljnje preiskave.
When and how should you take Protium?
Kdaj in kako morate jemati zdravilo Protium?
Take your next normal dose at the usual time.
Vzemite naslednji normalni odmerek ob običajnem času.
(Part of a) hospital pack - not to be sold separately.
(Del) bolnišničnega pakiranja - se ne prodaja ločeno.
An excessive increase, however, occurs only in isolated cases.
Do izjemnega porasta pa pride samo v posameznih primerih.
Only very small amounts of pantoprazole are dialyzed.
Dializirajo se samo zelo majhne količine pantoprazola.
After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Kot je zahtevano, bodo po odločbi Komisije pristojni organi držav članic v povezavi z referenčno državo članico posodobili podatke o zdravilu.
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
To zdravilo mora aplicirati zdravstveni delavec pod ustreznim medicinskim nadzorom.
Take the two tablets 1 hour before a meal.
Vzemite obe tableti 1 uro pred obrokom.
After consultation with your doctor, the dose may be doubled.
Po posvetu z vašim zdravnikom se lahko odmerek podvoji.
Unless told otherwise by your doctor, the usual dose is:
Če vam zdravnik ne predpiše drugače, je običajen odmerek:
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če ni takoj uporabljena, so čas in pogoji shranjevanja do uporabe odgovornost uporabnika.
Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents.
Upoštevati je treba uradne smernice (npr. nacionalna priporočila) glede bakterijske rezistence in primerne uporabe ter predpisovanja protimikrobnih zdravil.
Tablets will replace your injections as soon as your doctor sees fit.
Tablete bodo zamenjale injekcije, kakor hitro bo vaš zdravnik menil, da je to ustrezno.
The absolute bioavailability from the tablet was found to be about 77 %.
Absolutna biološka razpoložljivost tablete znaša približno 77%.
The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.
Namen je znebiti se bakterije in tako zmanjšati verjetnost, da se te razjede povrnejo.
Detailed information on this medicinal product is available on the website of the Heads of Medicines Agencies (HMA) http://www.hma.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
On short-term use, in most cases they do not exceed the upper limit of normal.
Pri kratkotrajni uporabi te vrednosti običajno ne presegajo zgornje meje normale.
You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Svojemu zdravniku morate opisati katerekoli nove in nenavadne simptome ter stanja, kadarkoli ga obiščete.
This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets.
To zdravilo se injicira v veno in ga boste dobili le, če vaš zdravnik meni, da so injekcije pantoprazola trenutno za vas bolj primerne kot pantoprazol tablete.
The contents of the vial are for single use only.
Vsebina viale je samo za enoodmerno uporabo.
Concomitant intake of food had no influence on AUC, maximum serum concentration and thus bioavailability.
Sočasno zaužitje hrane ne vpliva na AUC, na maksimalno koncentracijo v serumu in na biološko razpoložljivost.
As with healthy subjects, pantoprazole's half-life is short.
Kot pri zdravih osebah je razpolovni čas pantoprazola kratek.
The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1 % of patients.
Najpogosteje zabeležena neželena učinka sta driska in glavobol, oba se pojavita pri približno 1% bolnikov.
Your doctor may prescribe a temporary dose of more than four vials (160 mg) a day.
Zdravnik vam lahko predpiše začasni odmerek večji kot 4 viale (160 mg) na dan.
Terminal half-life is about 1 hour and clearance is about 0.1 l/h/kg.
Končni razpolovni čas je približno 1 ura in očistek je približno 0,1 l/h/kg.
Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain
Luksemburg Nizozemska Norveška Poljska Portugalska Romunija Slovaška Slovenija Španija
Take special care with Protium - If you have severe liver problems.
Bodite posebno pozorni pri zdravilu Protium - če imate hude težave z jetri.
The effect is the same whether the product is given orally or intravenously.
Učinek je enak ne glede na to ali damo zdravilo peroralno ali intravensko.
Data are available on intravenous use for up to 7 days.
Podatki o intravenski uporabi so na voljo za trajanje zdravljenja do 7 dni.
He will check your liver enzymes more frequently.
Pogosteje vam bo kontroliral jetrne encime.
If you take Protium on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance.
Če jemljete zdravilo Protium dolgoročno (več kot 1 leto) vas bo vaš zdravnik verjetno redno spremljal.
Pharmacokinetics do not vary after single or repeated administration.
Farmakokinetika se po enkratnem ali večkratnem vnosu ne razlikuje.
Volume of distribution is about 0.15 l/kg
Porazdelitveni volumen je približno 0,15 l/kg.
Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before your evening meal.
Vzemite prvo tableto pantoprazola 1 uro pred zajtrkom in drugo tableto pantoprazola 1 uro pred vašim večernim obrokom.
If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.
Če vam zdravnik predpiše dnevni odmerek večji od 4 tablet na dan, vam bo natančno povedal, kdaj prenehajte z jemanjem zdravila.
During long-term treatment, gastrin levels double in most cases.
Pri dolgotrajnem zdravljenju se nivoji gastrina večinoma podvojijo.
Distribution Pantoprazole's serum protein binding is about 98 %.
Vezava pantoprazola na serumske beljakovine je približno 98%.
If you have severe liver problems.
- če imate hude težave z jetri.
The combination therapy is implemented for 7 days in general and can be prolonged for a further 7 days to a total duration of up to two weeks.
Kombinirano zdravljenje običajno traja 7 dni in se lahko podaljša za nadaljnjih 7 dni, s skupnim trajanjem do dva tedna.
Name of the medicine
IME ZDRAVILA
Follow your doctor's instructions and make sure you read the package leaflets for these antibiotics.
Upoštevajte navodila vašega zdravnika in zagotovo preberite navodila za uporabo predpisanih antibiotikov.
The half-life of the main metabolite (about 1.5 hours) is not much longer than that of pantoprazole.
Razpolovni čas glavnega presnovka (približno 1,5 ure) ni dosti daljši od pantoprazolovega.
As a result, concentration of pantoprazole in the foetus is increased shortly before birth.
Rezultat je zvišana koncentracija pantoprazola v plodu malo pred porodom.
Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Neželeni učinki pantoprazola v kliničnih študijah in poročilih o post-marketinših izkušnjah
It is used for treating acid-related diseases of the stomach and intestine.
Uporablja se za zdravljenje s kislino povezanih bolezni želodca in črevesja.
Please tell your doctor if you ever had problems with your liver in the past.
Prosim povejte svojemu zdravniku, če ste kdaj v preteklosti imeli težave z jetri.
Excretion into human milk has been reported.If you are pregnant, or think you may be pregnant, or if you are breast-feeding, you should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.
Če ste noseči ali mislite, da bi bili lahko noseči ali če dojite, smete uporabljati to zdravilo samo, če vaš zdravnik meni, da je za vas korist večja kot je možno tveganje za vašega nerojenega otroka ali dojenčka.
For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.
Vse neželene učinke zabeležene v post-marketinških izkušnjah ni mogoče uvrstiti v ustrezno pogostnost in so zato navedeni v klasifikaciji pogostnosti »neznana«.
A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg).
Rahel porast neoplastičnih sprememb v ščitnici so opazili pri skupini podgan, ki so dobivale največje odmerke (200 mg/kg).
If your symptoms continue in spite of your treatment, further investigations will be considered.
Če se vaši simptomi kljub zdravljenju nadaljujejo, pridejo v poštev nadaljnje preiskave.
In the two-year carcinogenicity studies in rats neuroendocrine neoplasms were found.
Pri podganah so v dvoletnih karcinogenetskih študijah ugotovili nevroendokrine neoplazme.
In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
V primeru prevelikega odmerjanja s kliničnimi znaki zastrupitve ni razen simptomatskega in podpornega zdravljenja nobenih specifičnih priporočil za zdravljenje.
Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori:
Odvisno od rezistence so za eradikacijo H. pylori priporočene naslednje kombinacije:
WHAT PROTIUM IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PROTIUM IN ZA KAJ GA UPORABLJAMO
Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it.
Vaš zdravnik naj se odloči, ali so potrebne dodatne preiskave, da se izključi maligno obolenje, ker pantoprazol tudi zmanjša simptome raka in lahko povzroči zakasnitev diagnoze.
In long-term treatment, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.
Dolgotrajno zdravljenje Pri dolgotrajnem zdravljenju, zlasti kadar to presega obdobje 1 leta, je treba bolnike redno spremljati.