natgillin/translations-raw huggingface dataset:
Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow.
Eritropoetin proizvajajo ledvice, spodbuja pa tvorbo rdečih krvnih celic iz kostnega mozga.
What is the risk associated with NeoRecormon?
Kakšna tveganja so povezana z zdravilom NeoRecormon?
The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production.
Epoetin beta v zdravilu NeoRecormon v telesu na enak način spodbuja nastajanje rdečih krvnih celic kot naravno prisotni hormon.
NeoRecormon is used in the following situations:
Zdravilo NeoRecormon se uporablja za:
For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery.
Pri bolnikih s kronično ledvično odpovedjo se lahko zdravilo NeoRecormon injicira v veno ali v podkožje, ne sme pa se injicirati v podkožje pri nedonošenčkih in bolnikih na kemoterapiji, medtem ko se mora pri bolnikih, ki so pred odvzemom krvi za kirurški poseg, injicirati v veno.
For more details, see the package leaflet.
Za več informacij glejte navodilo za uporabo.
Why has NeoRecormon been approved?
Zakaj je bilo zdravilo NeoRecormon odobreno?
• to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.
• povečevanje količine krvi, ki se lahko odvzame odraslim bolnikom z zmerno anemijo, ki čakajo na kirurški poseg, za katerega bodo potrebovali zalogo lastne krvi (avtologna transfuzija krvi).
What is NeoRecormon used for?
Za kaj se zdravilo NeoRecormon uporablja?
How has NeoRecormon been studied?
Kako je bilo zdravilo NeoRecormon raziskano?
How is NeoRecormon used?
Kako se zdravilo NeoRecormon uporablja?
What is NeoRecormon?
Kaj je zdravilo NeoRecormon?
How does NeoRecormon work?
Kako zdravilo NeoRecormon deluje?
Benefit/risk
Koristni učinki/tveganje
In Norway most of these activities were implemented already in 1995 without any effect on the way the product was prescribed and used.
Na Norveškem so večino teh aktivnosti začeli izvajati že leta 1995 brez kakršnegakoli učinka na način predpisovanja in uporabe zdravila.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CARISOPRODOL (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO KARISOPRODOL (glejte Dodatek I)
The Marketing Authorisation Holder decided on the voluntary withdrawal on the basis of the assessment performed by the Norwegian Competent Authority.
Imetnik dovoljenja za promet se je odločil za prostovoljni umik na osnovi presoje, ki jo je izvedel nacionalni pristojni organ Norveške.
Alternative options are available in the EU for the concerned indications.
Za omenjene indikacije so v EU na voljo tudi druge možnosti.
• Data demonstrating that the products can be used safely taking into account information on intoxications from poison centres in Europe.
• podatke, ki kažejo, da se lahko zdravila uporabljajo na varen način, pri čemer je treba upoštevati informacije o zastrupitvah iz centrov za zastrupitve v Evropi;
The three observational studies published in Norway in 2007 gave evidence for the signals of abuse and impairment identified by the spontaneous reporting system in Norway.
V treh opazovalnih študijah, ki so bile objavljene na Norveškem leta 2007, so dokazali znake zlorabe in prizadetosti, ki so jih v okviru sistemu spontanega poročanja zabeležili na Norveškem.
• Data demonstrating convincing efficacy and safety derived from appropriately designed clinical trials (including an active comparator) and data justifying the proposed dose.
• podatke, ki kažejo prepričljivo učinkovitost in varnost in ki so bili pridobljeni v primerno načrtovanih preizkušanjih (vključno z aktivnim primerjalnim zdravilom), ter podatke, ki utemeljujejo priporočeni odmerek;
In addition there is information on spontaneous reports as well as reports from poison centers in Europe and in the US that there are problems related to intoxications.
Poleg tega obstajajo informacije o spontanih poročilih, kot tudi poročila iz centrov za zastrupitve v Evropi in v ZDA, ki navajajo, da obstajajo težave, povezane z zastrupitvami.
In addition there is data from poison information centres confirming these concerns.
Poleg tega obstajajo podatki iz informacijskih centrov za zastrupitve, ki potrjujejo te zadržke.
All carisoprodol containing medicinal products in the EU are authorised according to national procedures.
Vsa zdravila, ki vsebujejo karisoprodol, so v EU odobrena v skladu z nacionalnimi postopki.
Several risk minimisation activities (such as restriction of the indication, recommendation of only short term treatment, supply of only small package and change of the prescription category to a more restrictive) have been proposed by the MAHs.
Imetniki dovoljenj za promet so predlagali več ukrepov za zmanjšanje tveganja (kot so omejitev indikacije, priporočilo za kratkotrajno zdravljenje, oblikovanje manjših pakiranj in sprememba kategorije predpisovanja v bolj restriktivno).
These symptoms are attributable to the low therapeutic index of carisoprodol.
Te simptome je mogoče pripisati nizkemu terapevtskemu indeksu karisoprodola.
Medicinal products containing carisoprodol have been available in Europe since 1959 and are authorised in a number of EU Member States (see Annex I for the list of carisoprodol containing medicinal products authorised in the EU).
Zdravila, ki vsebujejo karisoprodol, so v Evropi na voljo od leta 1959 in so odobrena v številnih državah članicah EU (za seznam zdravil, ki vsebujejo karisoprodol in so odobrena v EU, glejte Dodatek I).
• Detailed risk minimisation measures and ways to ensure that the impact of such measures could be adequately evaluated once in place.
• podrobno opisane ukrepe za zmanjšanje tveganj in načine zagotavljanja vrednotenja takih ukrepov po začetku njihovega izvajanja.
For other indications authorised in some countries it must be concluded that the efficacy is not documented, but it is based on anecdotal reports on clinical effect.
Za druge indikacije, ki so odobrene v nekaterih državah, velja, da učinkovitost ni dokumentirana, temveč temelji na ustnih poročilih o kliničnih učinkih.
The pharmacokinetic part of the above mentioned study showed that the blood concentration curve of carisoprodol increases and falls rapidly.
Farmakokinetični del zgoraj omenjene študije je pokazal, da krivulja koncentracije karisoprodola v krvi hitro zraste in hitro pade.
In the recent observational studies the prescribing patterns continued to be distorted.
V zadnjih opazovalnih študijah so še vedno opažali popačen vzorec predpisovanja.
The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting.
Odbor za zdravila za uporabo v humani medicini (CHMP) je o tem razpravljal na plenarnem zasedanju septembra 2007, postopek v skladu s členom 107(2) Direktive 2001/83/ES z vsemi spremembami pa se je začel na seji CHMP septembra 2007.
Furthermore the CHMP took note that there are other effective medications with a more favourable safety profile for the treatment of acute low back pain.
Poleg tega je CHMP ugotovil, da obstajajo druga učinkovita zdravila z bolj primernim varnostnim profilom za zdravljenje akutnih bolečin v spodnjem delu hrbta.
Acute lower back pain is the only indication that has been documented by three randomised, controlled clinical studies using carisoprodol 350mg performed in the 60's and 70's and which do not fulfill current stardard for the Phase III clinical trials.
Akutne bolečine v spodnjem delu hrbta so edina indikacija, ki so jo dokumentirali v treh randomiziranih, nadzorovanih kliničnih študijah karisoprodola 350 mg, ki pa so bile izvedene že v šestdesetih in sedemdesetih letih in ne izpolnjujejo današnjih kriterijev III. faze kliničnih preizkušanj.
GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
PODLAGA ZA UMIK DOVOLJENJ ZA PROMET Z ZDRAVILI
On 20 April 2007, the Norwegian Competent Authority (NoMA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the decision by the Marketing Authorisation Holder Actavis to voluntarily withdraw as of 1 May 2008 the Marketing Authorisations for carisoprodol containing medicinal products in its Member State.
Dne 20. aprila 2007 je norveški pristojni organ (NoMA) izdal nujno obvestilo, s katerim je v skladu s členom 107 Direktive 2001/83/ES z vsemi spremembami obvestil države članice, agencijo EMEA in Evropsko komisijo o odločitvi imetnika dovoljenj za promet z zdravili, družbe Actavis, da bo s 1. majem 2008 v državi članici prostovoljno umaknila dovoljenja za promet z zdravili, ki vsebujejo karisoprodol.
The lack of recent safety studies comparing carisoprodol to other analgesic products with a better studied safety profile available for the same indication emphasizes the need for further systematic investigation.
Ker ni novejših študij varnosti, v katerih bi primerjali karisoprodol z drugimi analgetičnimi zdravili, ki imajo bolje raziskan varnostni profil za isto indikacijo, je potrebno nadaljnje sistematično raziskovanje.
Therefore, in practice a safe pattern of use of carisoprodol containing products is difficult to achieve in many patients.
Zato je v praksi pri številnih bolnikih težko doseči varen vzorec uporabe zdravil, ki vsebujejo karisoprodol.
They include tablets and supositories available under prescription in 12 EU Member States.
Zdravila so v obliki tablet in svečk in so na voljo na recept v 12 državah članicah EU.
The Committee considered that carisoprodol is indicated primarily for acute low back pain, however, because of the nature of low back pain this has resulted in a tendency for more chronic use of the drug, increasing the risk of dependence.
Odbor je upošteval, da je karisoprodol indiciran predvsem za akutne bolečine v spodnjem delu hrbta, vendar pa je zaradi narave bolečine slednje prispevalo k bolj kronični uporabi zdravila in s tem k zvišanju tveganja odvisnosti.
The study gave support to earlier work published on the impairing effects of carisoprodol.
Študija je podprla predhodno objavljene prispevke, ki so obravnavali škodljive učinke karisoprodola.
The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing carisoprodol;
Odbor je upošteval postopek iz člena 107 Direktive 2001/83/ES z vsemi spremembami za zdravila, ki vsebujejo karisoprodol.
The Committee considered that the efficacy of carisoprodol containing products is poorly documented; only three relatively old studies are available to demonstrate efficacy in acute low back pain.
Odbor je upošteval, da učinkovitost zdravil, ki vsebujejo karisoprodol, ni dobro dokumentirana, saj so na razpolago le tri relativno stare študije, ki dokazujejo učinkovitost pri bolečinah v spodnjem delu hrbta.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJ ZA PROMET, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
In one of these studies it was concluded that patients receiving carisoprodol seemed to have an increased risk of being involved in traffic accidents involving person injury.
V eni od teh študij so zaključili, da je bilo pri bolnikih, ki so prejemali karisoprodol, povečano tveganje udeležbe v prometnih nesrečah s telesnimi poškodbami.
The proof of efficacy for different dosing of carisoprodol and for combination products is missing completely.
V celoti manjka dokaz učinkovitosti pri različnih odmerkih karisoprodola in za kombinacijska zdravila.
The Committee in light of the above findings concluded that the benefit/risk balance of carisoprodol containing medicinal products is no longer positive.
Odbor je na podlagi zgoraj omenjenih ugotovitev zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo karisoprodol, ni več pozitivno.
Carisoprodol is a centrally acting drug mainly indicated for short-term treatment of acute lower back pain.
Karisoprodol je centralno delujoče zdravilo, ki je v glavnem indicirano za kratkotrajno zdravljenje akutnih bolečin v spodnjem delu hrbta.
The serum concentrations for carisoprodol together with the pharmacodynamic results on somnolence found in this study clearly confirmed the Norwegian observational study results that there should be strong warnings against the use of motor vehicle due to somnolence when using carisoprodol medication.
Serumske koncentracije karisoprodola in farmakodinamični rezultati glede somnolence iz te študije so jasno potrdili rezultate norveške opazovalne študije, po kateri bi morala obstajati jasna opozorila, ki odsvetujejo uporabo motornih vozil zaradi nevarnosti somnolence, ki se pojavi pri uporabi zdravil s karisoprodolom.
A number of articles describing its abuse potential, toxicity and dependence have been published.
Objavljeni so bili številni prispevki, ki opisujejo njegov potencial za zlorabo, toksičnost in odvisnost.
Thus the CHMP recommended the suspension of the Marketing Authorisations for all carisoprodol containing medicinal products listed in Annex I. For the suspension to be lifted the Marketing Authorisation Holders would need to provide:
Zato je CHMP priporočil umik dovoljenj za promet z vsemi zdravili, ki vsebujejo karisoprodol in so navedena v Dodatku I. Za preklic umika dovoljenj morajo imetniki dovoljenj za promet priskrbeti:
This means that adverse drug reactions related to high carisoprodol concentrations are easier to identify.
To pomeni, da je lažje identificirati neželene reakcije na zdravila, ki so povezane z visokimi koncentracijami karisoprodola.
In the results from the study which was submitted during this procedure sedation, psychomotor impairment and other impairments were observed about 1.5 hour after ingestion, indicating these are effects associated with carisoprodol itself and not its metabolites.
V rezultatih študije, ki je bila predložena v tem postopku, so ugotovili sedacijo, psihomotorično prizadetost in druge prizadetosti približno 1,5 ure po zaužitju, kar je kazalo na to, da so ti učinki povezani s samim karisoprodolom in ne njegovimi presnovki.
There are several scientific publications analysing the adverse effects of intoxication and psychomotor impairment.
Na voljo je več znanstvenih publikacij, ki analizirajo neželene učinke zastrupitve in psihomotorične prizadetosti.
Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for carisoprodol is not considered favourable and recommended the suspension of the Marketing Authorisations for the medicinal products referred to in Annex I.
Ob upoštevanju vseh naštetih elementov je CHMP prišel do zaključka, da je razmerje med koristmi in tveganji za karisoprodol neugodno, in je priporočil umik dovoljenj za promet z zdravili, ki so navedena v Dodatku I.
The MAHs of carisoprodol containing products have not provided any sound clinical data, which would demonstrate the efficacy of carisoprodol.
Imetniki dovoljenj za promet z zdravili, ki vsebujejo karisoprodol, niso priskrbeli nobenih tehtnih kliničnih podatkov, ki bi dokazovali učinkovitost karisoprodola.
As pharmacological studies with carisoprodol have been limited to single dose studies, there have been some uncertainties to the mechanism for the observed effects of carisoprodol and whether they are associated with carisoprodol itself or with its metabolites.
Ker so bile farmakološke študije karisoprodola omejene na študije uporabe enega samega odmerka, so obstajale nekatere nejasnosti glede mehanizma opaženih učinkov karisoprodola in stopnje, do katere so ti povezani s samim karisoprodolom ali njegovimi presnovki.
In this perspective it is considered that unless the risk minimisation measures can be monitored and their impact can be evaluated accurately they could not be a valuable point in the evaluation of the use of carisoprodol.
Zaradi tega je bilo sprejeto mnenje, da ukrepi za zmanjšanje tveganja ne bodo koristni pri vrednotenju rabe karisoprodola, če se le-ti ne bodo nadzorovali, njihovi učinki pa natančno vrednotili.
Carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Karisoprodol je povezan s tveganjem za zlorabo, psihomotorično prizadetost in zastrupitev.
The Committee concluded that there is increasing evidence for carisoprodol-associated risk of abuse, psychomotor impairment and intoxications.
Odbor je zaključil, da obstaja vedno več dokazov o tveganju za zlorabo, psihomotorično prizadetost in zastrupitev, ki so povezane s karisoprodolom.
There is available evidence that carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Na voljo so dokazi, da je učinkovina karisoprodol povezana s tveganjem za zlorabo, psihomotorično prizadetost in zastrupitev.
Tritazide has been authorised in the EU since 1993, first in Germany and then in the following countries: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Zdravilo Tritazide je odobreno v EU od leta 1993 in je bilo najprej odobreno v Nemčiji, nato pa še v naslednjih državah: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Luksemburg, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Švedska.
Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, o napotitvi na podlagi različnih odločitev, ki so jih sprejele države članice.
Tritazide can also be available in the EU and the EEA under other trade names: Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite,Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark..
Zdravilo Tritazide je lahko v EU in EGP na voljo tudi pod naslednjimi imeni: Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite,Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur in Idroquark.
Tritazide is authorised in the European Union (EU) via national procedures.
Zdravilo Tritazide je v Evropski uniji (EU) odobreno z nacionalnimi postopki.
Ref. EMEA/CHMP/204584/2009
EMEA/203002/2009
Why was Tritazide reviewed?
Zakaj je bilo zdravilo Tritazide pregledano?
In most cases the initial recommended dose was the same, but there were differences with respect to subsequent titration (both in terms of frequency of increase and maximum daily dose).
V večini primerov je bil začetni priporočeni odmerek enak, vendar so obstajale razlike glede nadaljnje titracije (glede pogostnosti povečanja in največjega dnevnega odmerka).
Tritazide and associated names should be started at the lowest available dosage.
Zdravilo Tritazide in z njim povezana imena je treba začeti jemati pri najnižjem odmerku, ki je na voljo.
The European Medicines Agency (EMEA) has completed a review of Tritazide.
Evropska agencija za zdravila (EMEA) je zaključila pregled zdravila Tritazide.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Odmerek je treba prilagoditi posamezniku skladno z njegovim profilom (glejte poglavje 4.4) in nadzorom krvnega tlaka.
• Treatment of hypertension
• zdravljenje hipertenzije,
The CHMP included also new warnings for: pregnancy, surgery, electrolyte disturbances, and cough.
CHMP je poleg tega vključil tudi nova opozorila za: nosečnost, kirurške posege, elektrolitske motnje in kašelj.
The company that markets Tritazide is Sanofi-aventis.
Družba, ki trži zdravilo Tritazide, je Sanofi-aventis.
• Clinically relevant electrolyte disturbances which may worsen following treatment with
• Klinično pomembne motnje elektrolitov, ki lahko poslabšajo zdravljenje z zdravilom
The CHMP adopted the following harmonised wording:
CHMP je sprejel naslednje usklajeno besedilo:
The CHMP discussed the areas where there was a divergence identified in the dose recommendations.
CHMP je razpravljal o področjih, na katerih je prišlo do razhajanj pri priporočilih glede odmerka.
4.5 Interactions
4.5 Medsebojno delovanje
It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Deluje tako, da poveča tvorjenje urina in pri tem zmanjša količino tekočine v krvi, s tem pa tudi zniža krvni tlak.
This is in line with the recommendation of the CHMP's Pharmacovigilance Working Party on use of ACE inhibitors in pregnancy.
To je skladno s priporočilom delovne skupine za farmakovigilanco odbora CHMP v povezavi z uporabo zaviralcev angiotenzinske konvertaze med nosečnostjo.
• Severe impairment of liver function, hepatic encephalopathy
• Močno poslabšana jetrna funkcija, hepatična encefalopatija.
• Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
• Zunajtelesna zdravljenja, pri katerih pride do stika krvi z negativno naelektrenimi površinami (glejte poglavje 4.5).
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
To je v državah članicah privedlo do razhajanj glede uporabe zdravila, kot je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanja in navodila za uporabo v državah, v katerih je zdravilo na trgu.
The combination ramipril 2.5 mg/ HCTZ 12.5 mg led to greater reduction in blood pressure than the treatment with individual components and the combination of 5 mg/25 mg produced a better therapeutic effect than doubling the ramipril dose to 10 mg.
Kombinacija ramiprila 2,5 mg/hidroklorotiazid 12,5 mg je povzročila večji padec krvnega tlaka kot zdravljenje s posamezno zdravilo učinkovino, kombinacija 5 mg/25 mg pa je imela za posledico boljše zdravilne učinke kot podvojitev odmerka ramiprila na 10 mg.
• 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
• 2. in 3. tromesečje nosečnosti (glejte poglavji 4.4 in 4.6).
The CHMP endorsed the current list of products which interact or may interact with Tritazide, including additional text reinforcing lithium toxicity.
CHMP je podprl trenutno veljaven seznam zdravil, ki medsebojno delujejo z zdravilom Tritazide, ali bi do tega utegnilo priti, vključno z dodatnim besedilom, ki je poudaril toksičnost litija.
• Severe impairment of renal function with a creatinine clearance below 30 ml/min in undialysed patients
• Močno poslabšana ledvična funkcija, kjer je očistek kreatinina pri nedializiranih bolnikih manjši od 30 ml/min.
The majority of the contraindications are related to use of ramipril as a component of Tritazide.
Večina kontraindikacij je povezanih z uporabo ramiprila kot sestavine zdravila Tritazide.