natgillin/translations-raw huggingface dataset:
Severe hepatic impairment
Bolezni živčevja glavobol
Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
Pri bolnikih z anamnezo splenektomije, zdravljenih z lusutrombopagom, je treba skrbno spremljati število trombocitov.
if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL increase from baseline.
Če število trombocitov doseže ≥ 50.000/µl, ker se je zvečalo za 20.000/µl od izhodišča, je treba izvesti ustrezne ukrepe, na primer ukinitev lusutrombopaga.
Children and adolescents
Nosečnost in dojenje
Embryo-foetal development
Razvoj zarodka in ploda
The duration of the increase in platelet count to ≥ 50,000/µL in Studies M0631 and M0634 and the pooled (Studies M0631 and M0634) lusutrombopag group was significantly greater than compared with placebo (Table 5).
M0631 in M0634) skupini z lusutrombopagom je bilo značilno daljše kot pri placebu (preglednica 5).
Appropriate measures such as discontinuation of lusutrombopag should be taken, if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL
≥ 50.000/µl, ker se je zvečalo za 20.000/µl od izhodišča, je treba izvesti ustrezne ukrepe, na primer ukinitev lusutrombopaga.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
Medicinal product subject to medical prescription.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom
≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline) during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 4).
Trajanje zvečanja števila trombocitov na ≥ 50.000/μl Trajanje zvečanja števila trombocitov na ≥ 50.000/μl v študijah M0631 in M0634 in v združeni (študiji
Overall
Skupaj
Treatment Group
Appelhof 13
Table 1 Adverse reactions System Organ Class
Preglednica 1 Neželeni učinki
Mulpleo contains sodium
Shranjevanje zdravila Mulpleo
There were no effects on pregnancy, parturition, lactation in F0 dams and postnatal development in F1 pups at doses up to 12.5 mg/kg/day (89 times the human clinical exposures in adults based on AUC).
Pri odmerkih do 12,5 mg/kg/dan (89-krat večja izpostavljenost od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC) ni bilo učinkov na brejost, porod, laktacijo pri F0 samicah in na poporodni razvoj pri F1 mladičih.
The patients were treated for 4 weeks.
Bolniki so zdravilo prejemali 4 tedne.
The recommended dose is one tablet per day for up to 2 weeks until the symptoms are relieved.
Priporočeni odmerek je ena tableta na dan v obdobju do 2 tednov, dokler se simptomi ne izboljšajo.
The Committee concluded that patients could safely treat themselves with the medicine for up to 2 weeks.
Odbor je zaključil, da se lahko bolniki s tem zdravilom varno zdravijo sami do 2 tedna.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Pojasnjuje, kako je Agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
The CHMP concluded that the medicine's effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients' symptoms cleared up in 2 weeks.
CHMP je zaključil, da so učinki zdravila že dobro znani, saj so zdravila, ki vsebujejo esomeprazol, odobrena za uporabo v državah EU že od leta 2000, in da so bile njegove kratkotrajne koristi prikazane v študijah, v katerih so simptomi pri večini bolnikov izginili v 2 tednih.
The full EPAR for Nexium Control 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 Nexium Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
If symptoms persist after 2 weeks, the patient should see a doctor.
Če se simptomi po 2 tednih ne izboljšajo, naj se bolnik posvetuje z zdravnikom.
The main measure of effectiveness in both studies was the percentage of patients whose heartburn symptoms had completely cleared up at the end of the study.
Glavno merilo učinkovitosti v obeh študijah je bil odstotek bolnikov, pri katerih so simptomi zgage na koncu študije popolnoma izginili.
This is a summary of the European public assessment report (EPAR) for Nexium Control.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nexium Control.
The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Evropska komisija je dovoljenje za promet z zdravilom Nexium Control, veljavno po vsej Evropski uniji, odobrila dne 26. avgusta 2013.
It is available as tablets (20 mg) which are gastro-resistant (the contents pass through the stomach without being broken down until they reach the intestine).
Zdravilo je na voljo v obliki gastrorezistentnih tablet (20 mg) (vsebina preide skozi želodec, ne da bi se tableta razgradila, dokler ne pride v črevesje).
In both studies, most patients whose symptoms completely cleared up had already achieved this in the first 2 weeks, while patients whose symptoms did not completely clear up in 2 weeks showed little further improvement from continued treatment.
V obeh študijah je večina bolnikov, pri katerih so simptomi popolnoma izginili, to dosegla že v prvih 2 tednih, pri bolnikih, pri katerih simptomi niso izginili v 2 tednih, pa so zabeležili le minimalno dodatno izboljšanje pri nadaljevanju zdravljenja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Nexium Control večje od z njim povezanih tveganj, in priporočil, da se zdravilo odobri za uporabo v EU.
The reference medicine is only available with a prescription, but Nexium Control is intended for short term use without a prescription.
Referenčno zdravilo je na voljo le na recept, zdravilo Nexium Control pa je namenjeno kratkotrajni uporabi brez recepta.
What measures are being taken to ensure the safe and effective use of Nexium Control?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nexium Control?
Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Zdravila Nexium Control se ne sme uporabljati sočasno z drugim zdravilom, ki se imenuje nelfinavir (uporablja se za zdravljenje okužbe s HIV).
A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Nexium Control je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nexium Control, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Nexium Control vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Zdravilo Nexium Control so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v katerih je sodelovalo 718 odraslih bolnikov s simptomi refluksa, vključno z zgago.
It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Zdravilo se uporablja za kratkotrajno zdravljenje simptomov refluksa (imenovanega tudi refluks kisline), npr. zgage in regurgitacije kisline, pri odraslih.
By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Esomeprazol z zaviranjem črpalk zmanjša izločanje kisline ter tako izboljša simptome refluksa kisline.
Other information about Nexium Control
Druge informacije o zdravilu Nexium Control
It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Esomeprazol deluje tako, da zavira „protonske črpalke“, tj. beljakovine v specializiranih celicah stene želodca, ki črpajo kislino v želodec.
For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Nexium Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Nexium Control, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Nexium Control, glejte navodilo za uporabo.
For practical information about using Nexium Control, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Nexium Control naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Nexium Control is a medicine that contains the active substance esomeprazole.
Nexium Control je zdravilo, ki vsebuje zdravilno učinkovino esomeprazol.
Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Zdravilo Nexium Control je podobno „referenčnemu zdravilu“ Nexium, ki je že odobreno za uporabo v Evropski uniji (EU) in vsebuje enako zdravilno učinkovito.
In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124).
V prvi študiji so pri bolnikih, ki so prejemali 20 mg zdravila Nexium Control, simptomi zgage izginili pri približno 34 % (pri 41 od 121) bolnikov v primerjavi s približno 14 % bolnikov (17 od 124), ki so prejemali placebo.
What benefits of Nexium Control have been shown in studies?
Kakšne koristi je zdravilo Nexium Control izkazalo v študijah?
What is Nexium Control and what is it used for?
Kaj je zdravilo Nexium Control in za kaj se uporablja?
In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118).
V drugi študiji so pri bolnikih, ki so prejemali zdravilo Nexium Control, simptomi zgage izginili pri približno 42 % bolnikov (pri 47 od 113) v primerjavi s približno 12 % bolnikov, ki so prejemali placebo (14 od 118).
What are the risks associated with Nexium Control?
Kakšna tveganja so povezana z zdravilom Nexium Control?
Why is Nexium Control approved?
Zakaj je bilo zdravilo Nexium Control odobreno?
The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Zdravilna učinkovina v zdravilu Nexium Control je esomeprazol, ki je zaviralec protonske črpalke.
It is not intended to provide practical advice on how to use Nexium Control.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Nexium Control can be obtained without a prescription.
Izdaja zdravila Nexium Control je brez recepta.
How does Nexium Control work?
Kako zdravilo Nexium Control deluje?
How is Nexium Control used?
Kako se zdravilo Nexium Control uporablja?
Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients).
Najpogostejši neželeni učinki zdravila Nexium Control (opaženi pri največ 1 od 10 bolnikov) so glavobol, bolečine v trebuhu, driska in navzea.
The clinical significance of this is not clear.
Klinični pomen tega ni jasen.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 14. april 2011
The volume of distribution is about 0.5 l/kg.
Volumen porazdelitve je približno 0,5 l/kg.
Practically all the drug is eliminated within 6 days.
Skoraj vsa količina zdravila se izloči v 6 dneh.
- You should always keep your alcohol intake to a minimum.
- Pitje alkohola morate vedno omejiti na najmanjšo možno mero.
These changes are specific to small rodents and have not been observed in other animal species.
Te spremembe so specifične za male glodavce in jih pri drugih živalskih vrstah niso opazili.
Swallow the capsule with water.
Kapsulo pogoltnite z vodo.
The following two side effects are important and will require immediate action.
Naslednji neželeni učinki so pomembni in zahtevajo takojšnje ukrepanje.
This combination is, therefore, not recommended.
Kombinacija zato ni priporočljiva.
- Children and adolescents (age below 18 years).
- Otroci in mladostniki (mlajši od 18 let).
B-1080 Brussels
B-1080 Bruselj
The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown.
Mehanizem tega medsebojnega delovanja (bodisi da gre za farmakodinamiko ali farmakokinetiko, ali pa oboje) še ni znan.
- Tell your doctor about all your medical conditions including allergies.
- Opišite mu vaše celotno zdravstveno stanje, vključno z alergijami.
Elderly patients (≥ 65 years old)
Posebne skupine Starejši bolniki (≥ 65 let)
Do not take Pravafenix if you are pregnant or trying to get pregnant or think you may be pregnant.
Zdravila Pravafenix ne jemljite, če ste noseči, če skušate zanositi ali če menite, da bi lahko bili noseči.
Adverse reactions have usually been mild and transient.
Neželeni učinki so bili običajno blagi in prehodni.
They may raise your risk of having heart problems.
Ti lahko povečajo vaše tveganje za bolezni srca.
This is of no relevance to therapeutic use in man.
Za terapevtsko uporabo pri človeku to ni pomembno.
If confirmed, the treatment should definitively not be initiated (see section 4.3).
Če so potrjeni, se zdravljenje vsekakor ne sme začeti (glejte poglavje 4.3).
This is due to the fat content of the meal.
Do tega pride zaradi maščob, ki jih vsebuje obrok.
If you are concerned about how much alcohol you can drink while you are taking this medicine, you should discuss this with your doctor.
Če vas skrbi, koliko alkohola lahko med jemanjem tega zdravila popijete, se o tem posvetujte z zdravnikom.
This is to check how well your liver and your kidneys are working.
S tem bo preveril, ali vaša jetra in ledvice dobro delujejo.
Response to therapy should be monitored by determination of serum lipid values.
Odziv na terapijo je treba spremljati z določanjem vrednosti serumskih lipidov.
This clogging can slow or block blood flow to vital organs such as the heart and brain.
Zožitve lahko upočasnijo ali prekinejo dotok krvi v življenjsko pomembne organe, kot sta srce in možgani.
Before treatment initiation
Pred začetkom zdravljenja
HDL cholesterol levels are frequently increased.
Ravni holesterola HDL se pogosto zvišajo.
The food effect increases with the fat content: the larger the lipid content the larger the bioavailability of fenofibrate.
Vpliv hrane se povečuje z vsebnostjo maščob: večja kot je vsebnost lipidov, večja je biološka uporabnost fenofibrata.
If you plan to become pregnant or become pregnant, inform your doctor immediately.
Če načrtujete nosečnost ali če ste zanosili, o tem takoj obvestite zdravnika.
For any information over this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Fenofibratna kislina je močno vezana na plazemske albumine (več kot 99-odstotno).
Do not take a double dose to make up for a forgotten dose, just take your normal amount of Pravafenix at the usual time the next day.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, vzemite le običajno količino zdravila Pravafenix naslednji dan ob istem času kot običajno.
The results of this study show that food has effect on the rate and extent of absorption in the fixed dose combination.
Rezultati te študije kažejo, da hrana vpliva na hitrost in količino absorpcije fiksne kombinacije odmerkov.
Animal studies have not demonstrated any teratogenic effects.
Študije na živalih niso pokazale nobenih teratogenih učinkov.
• Memory loss
• izguba spomina,
It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.
Priporočljivo je, da se odmerek antikoagulantov na začetku zdravljenja zniža za eno tretjino in se nato po potrebi postopoma prilagodi v skladu s spremljanjem internacionalnega normaliziranega razmerja
Studies on mutagenicity of fenofibrate have been negative.
Študije o mutagenosti fenofibrata so bile negativne.
Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10 000 do < 1/1.000), zelo redki (< 1/10.000).
About 50% of circulating pravastatin is bound to plasma proteins.
Okoli 50 % krožečega pravastatina se veže na plazemske beljakovine.
∞, AUCt, and Cmax is of 111.88%, 114.06%, and 115.28% respectively.
Povečanje vrednosti AUC∞, AUCt in Cmax znaša 111,88 %, 114,06 % in 115,28 %.
Sudden severe allergic reactions including swelling of the face, lip, tongue or wind pipe which can cause great difficulty in breathing.
Nenadne hude alergijske reakcije, vključno z otekanjem obraza, ustnic, jezika ali sapnika, ki lahko močno otežijo dihanje.
Also see section 4 of this leaflet.
Glejte tudi poglavje 4 v tem navodilu.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes.
Ko jemljete to zdravilo, vas bo zdravnik skrbno spremljal, če imate sladkorno bolezen ali ste izpostavljeni tveganju za razvoj sladkorne bolezni.
The drug is excreted mainly in the urine.
Zdravilo se izloča pretežno z urinom.
The risk of muscle breakdown is greater in certain patients.
Pri nekaterih bolnikih je tveganje za razpad mišic večje.
Before you take Pravafenix you should tell your doctor if you have or have had any medical problems.
Pred zdravljenjem z zdravilom Pravafenix morate zdravniku povedati, če imate ali ste imeli kakršnekoli zdravstvene težave.
Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Študije o kronični toksičnosti niso odkrile relevantnih podatkov o specifični toksičnosti fenofibrata.
Plasma concentrations are stable during continuous treatment in any given individual.
Koncentracija v plazmi je med neprekinjenim zdravljenjem pri katerem koli danem posamezniku stabilna.
A small quantity of pravastatin passes into the human breast milk.
Majhna količina pravastatina preide v materino mleko.
The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Povečano tveganje za venske trombotične dogodke je morda povezano z zvišano ravnijo homocisteina, ki je dejavnik tveganja za trombozo, in z drugimi neopredeljenimi dejavniki.
Statin therapy may be re-introduced seven days after the last dose of fusidic acid.
Zdravljenje s statini se lahko ponovno uvede sedem dni po zadnjem odmerku fusidne kisline.
This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment.
Pomembnost tega tveganja pa je manjša od pomembnosti zmanjšanja vaskularnega tveganja pri uporabi statinov, zato to ne sme biti razlog za prekinitev zdravljenja.
Co-administration of this combination may cause increased plasma concentrations of both agents.
Sočasno uvajanje te kombinacije lahko povzroči povečano koncentracijo obeh zdravil v plazmi.
In view of this substantial first pass through the liver, plasma concentrations of pravastatin have only a limited value in predicting the lipid-lowering effect.
Glede na ta pomemben prvi prehod prek jeter ima koncentracija pravastatina v plazmi le omejeno vrednost pri predvidevanju vpliva na zniževanje koncentracije lipidov.
- To raise the level of your ‘good' cholesterol (HDL cholesterol).
- za zvišanje ravni „dobrega“ holesterola (holesterola HDL).
Based on conventional studies of safety pharmacology, repeated dose toxicity and toxicity on reproduction, there are no other risks for the patient than those expected due to the pharmacological mechanism of action.
Na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja za bolnika ni drugih tveganj razen tistih, ki so zaradi farmakološkega mehanizma delovanja pričakovana.
- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
- Znana fotoalergija ali fototoksična reakcija med zdravljenjem s fibrati ali ketoprofenom.
Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin)
Možni neželeni učinki, o katerih so poročali pri nekaterih statinih (isti vrsti zdravil za zniževanje holesterola kot je pravastatin)
In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation.
Pri podganah in miših so pri visokih odmerkih našli tumorje na jetrih, ki jih gre pripisati proliferaciji peroksisomov.
Polyamide-Aluminium-PVC/aluminium blister 2 years.
Pretisni omoti iz poliamida-aluminija-PVC/aluminija 2 leti
Studies in mice, rats and rabbits did not reveal any teratogenic effect.
Študije na miših, podganah in kuncih niso odkrile nobenih teratogenih učinkov.
On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%.
V povprečju se absorbira 34 % peroralno zaužitega odmerka, pri čemer absolutna biološka uporabnost znaša 17 %.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Zdravniku ali farmacevtu prav tako povejte, če se vam pojavi stalna oslabelost mišic.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
In vitro studies demonstrated that pravastatin is transported into hepatocytes and with substantially less intake in other cells.
Študije in vitro so pokazale, da se pravastatin prenaša v hepatocite, pri čemer je vnos v druge celice znatno manjši.
What pravafenix is and what it is used for
KAJ JE ZDRAVILO PRAVAFENIX IN ZA KAJ GA UPORABLJAMO
Special caution is recommended in women of childbearing potential to ensure proper understanding of the potential risk associated with pravastatin therapy during pregnancy.
Pri ženskah v rodni dobi se priporoča posebna previdnost, s čimer naj se zagotovi, da pravilno razumejo možno tveganje, povezano z zdravljenjem s pravastatinom med nosečnostjo.
After absorption, 66% of pravastatin undergoes a first-pass extraction through the liver, which is the primary site of its action and the primary site of cholesterol synthesis and clearance of LDLcholesterol.
Po absorpciji se 66 % pravastatina izloči s prvim prehodom skozi jetra, ki so primarno mesto njegovega delovanja ter primarno mesto za sintezo holesterola in čiščenje holesterola LDL.