natgillin/translations-raw huggingface dataset:
In addition, there remained concern over the safety of the long-term use of the ingredients ethanol and propylene glycol in children, and some groups of adults such as those with alcoholism.
Prav tako niso izključili pomislekov glede varnosti dolgotrajne uporabe sestavin etanol in propilenglikol pri otrocih in nekaterih skupinah odraslih, na primer pri osebah, ki trpijo za alkoholizmom.
Why was Levothyroxine Alapis reviewed?
Zakaj so zdravilo Levothyroxine Alapis ponovno pregledali?
The grounds for the referral were concerns raised by the UK related to the dropper insert as a proposed administration device, due to the large number of drops that may be required and concerns about its accuracy in delivering the required dose.
Razlogi za napotitev so bili pomisleki Združenega kraljestva glede predlaganega pripomočka za dajanje, tj. kapalnega vložka, s katerim je treba odmeriti veliko število kapljic, in pomisleki v zvezi z natančnostjo odmerjanja.
What is Levothyroxine Alapis?
Kaj je zdravilo Levothyroxine Alapis?
Alapis S.A. submitted an application for Levothyroxine Alapis to the Dutch medicines regulatory agency for a decentralised procedure.
Družba Alapis S.A. je nizozemski regulatorni agenciji za zdravila predložila vlogo za pridobitev dovoljenja za promet z zdravilom Levothyroxine Alapis po decentraliziranem postopku.
The active substance in Levothyroxine Alapis, levothyroxine sodium, is a synthetic form of the hormone thyroxine.
Natrijev levotiroksin, zdravilna učinkovina v zdravilu Levothyroxine Alapis, je sintetična oblika hormona tiroksina.
Levothryoxine Alapis is a medicine that contains the active substance levothyroxine sodium.
Levothyroxine Alapis je zdravilo, ki vsebuje zdravilno učinkovino natrijev levotiroksin.
• a condition known as Hashimoto's thyroiditis, in which the immune system (the body's natural defences) attacks the thyroid causing it to swell and preventing it from working properly;
• stanja, imenovanega Hashimotov tiroiditis, pri katerem imunski sistem (naravna obramba telesa)
30 mg Capsule, hard Oral use bottle (HDPE)
Feraccru 30 mg kapsula, trda peroralna uporaba plastenka (HDPE) 56 kapsul
EU (MA) Number
Številka EU (dovoljenja za promet z zdravilom)
Feraccru
Jakost
This summary was last updated in 07-2012.
Povzetek je bil nazadnje posodobljen 07-2012.
It is used to treat the following infections in adults:
Uporablja se za zdravljenje naslednjih okužb pri odraslih:
‘Complicated' means that the infection is difficult to treat;
„Zapletena“ pomeni, da je okužbo težko zdraviti.
The standard dose of Doribax is 500 mg every eight hours.
Standardni odmerek zdravila Doribax je 500 mg vsakih osem ur.
The European Commission granted a marketing authorisation valid throughout the European Union for Doribax on 25 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Doribax, veljavno po vsej Evropski uniji, odobrila dne 25. julija 2008.
It works by attaching to certain types of protein on the surface of the bacteria cells.
Deluje tako, da se veže na določene vrste beljakovin na površini bakterijskih celic.
Treatment usually continues for between five and 14 days, depending on the type and severity of the infection and the patient's response (10 to 14 days are usually needed in nosocomial pneumonia).
Zdravljenje običajno traja od pet in 14 dni, odvisno od vrste in resnosti okužbe ter odziva bolnika (pri nozokomialni pljučnici je navadno potrebnih 10 do 14 dni).
Each infusion lasts for one hour, although some patients with nosocomial pneumonia may need infusions lasting four hours.
Vsaka infuzija traja eno uro, čeprav bodo morda nekateri bolniki z nozokomialno pljučnico potrebovali infuzijo, ki bo trajala štiri ure.
This is a summary of the European public assessment report (EPAR) for Doribax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Doribax.
The full EPAR for Doribax 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 Doribax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In all of the studies, the main measure of effectiveness was the number of patients whose infection
Glavno merilo učinkovitosti v vseh študijah je bilo število bolnikov, pri katerih je bila okužba po zdravljenju ozdravljena.
This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.
To bakterijam prepreči tvorjenje sten okoli svojih celic, zaradi česar odmrejo.
The CHMP decided that Doribax's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Doribax večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The most common side effect with Doribax (seen in more than 1 patient in 10) is headache.
Najpogostejši neželeni učinek zdravila Doribax (opažen pri več kot 1 od 10 bolnikov) je glavobol.
‘Nosocomial' means that the infection was caught in hospital, including pneumonia caused by the use of a ventilator (a machine that helps a
„Nozokomialna“ pomeni, da je do okužbe prišlo v bolnišnici, vključno s pljučnico, povzročeno zaradi respiratorja (naprave, ki pomaga bolniku dihati);
For more information about treatment with Doribax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Doribax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Doribax, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Doribax
Druge informacije o zdravilu Doribax
Before using Doribax, doctors should consider official guidance on the use of antibiotics.
Preden zdravnik predpiše zdravilo Doribax, mora upoštevati uradne smernice za uporabo antibiotikov.
What benefit has Doribax shown during the studies?
Kakšne koristi je zdravilo Doribax izkazalo med študijami?
It must not be used in patients who are severely allergic to other ‘beta-lactam' antibiotics, such as penicillins or cephalosporins.
Ne smejo ga uporabljati bolniki s hudimi alergijami na beta-laktam antibiotike, kot so na primer penicilini ali cefalosporini.
Doribax is an antibiotic.
Zdravilo Doribax je antibiotik.
Doribax was as effective as the other antibiotics in treating the infections:
Zdravilo Doribax je bilo pri zdravljenju okužb enako učinkovito kot drugi antibiotiki:
It is available as a powder to be made up into a solution for infusion (drip into a vein).
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno).
• nosocomial pneumonia (an infection of the lungs).
• nozokomialne ali bolnišnične pljučnice (okužbe pljuč).
The list of bacteria against which Doribax is active can be found in the summary of product characteristics (also part of
Seznam bakterij, proti katerim je zdravilo Doribax učinkovito, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
• complicated infections of the urinary tract (the structures that carry urine).
• zapletene okužbe sečil (organov, ki prenašajo urin).
Doribax must not be used in people who are hypersensitive (allergic) to doripenem or to other carbapenems.
Zdravila Doribax ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) doripenem ali druge karbapeneme.
The active substance in Doribax, doripenem, is an antibiotic that belongs to the group ‘carbapenems'.
Zdravilna učinkovina zdravila Doribax , doripenem, je antibiotik, ki spada v skupino „karbapenemov“.
When treating nosocomial pneumonia, a dose of 1 g every eight hours infused over four hours may be considered for patients who have augmented renal clearance (where the kidneys clear the medicine from the body too quickly) or whose infection is caused by certain types of bacteria.
Pri zdravljenju nozokomialne pljučnice pri bolnikih, pri katerih je ledvični očistek povečan (ledvice zdravilo izločijo iz telesa prehitro) ali pri katerih je okužbo povzročila določena vrsta bakterije, je možno 4-urno infundiranje zdravila v odmerku1 g vsakih osem ur.
Why has Doribax been approved?
Zakaj je bilo zdravilo Doribax odobreno?
What is the risk associated with Doribax?
Kakšna tveganja so povezana z zdravilom Doribax?
• complicated infections in the abdomen.
• zapletene trebušne okužbe.
Because the medicine is removed from the body by the kidneys, the dose should be reduced in patients who have moderately or severely reduced kidney function.
Ker zdravilo iz telesa izločajo ledvice, je pri bolnikih z zmerno ali hudo okvaro delovanja ledvic, treba odmerek zdravila Doribax zmanjšati.
For the full list of all side effects reported with Doribax, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Doribax, glejte navodilo za uporabo.
Doribax is a medicine containing the active substance doripenem.
Doribax je zdravilo, ki vsebuje zdravilno učinkovino doripenem.
• two studies compared Doribax with meropenem in a total of 962 patients with complicated
• v dveh študijah so zdravilo Doribax primerjali z meropenemom pri skupaj 962 bolnikih z zapletenimi trebušnimi okužbami;
• in complicated urinary tract infections, 82% of the patients receiving Doribax were cured (230 out of 280), compared with 83% of the patients receiving levofloxacin (221 out of 265).
• pri zapletenih okužbah sečil je ozdravelo 82 % bolnikov (230 od 280), ki so prejemali zdravilo Doribax, v primerjavi z 83 % bolnikov (221 od 265), ki so prejemali levofloksacin.
• one study compared Doribax with levofloxacin in 753 patients with complicated urinary tract
• v eni študiji so zdravilo Doribax primerjali z levofloksacinom pri skupaj 753 bolnikih z zapletenimi okužbami sečil.
How does Doribax work?
Kako zdravilo Doribax deluje?
• looking at the results of the two studies of complicated abdominal infections taken together, 85% of the patients receiving Doribax were cured (275 out of 325), compared with 84% of the patients receiving meropenem (260 out of 309);
• skupni rezultati obeh študij, pri katerih so sodelovali bolniki z zapletenimi trebušnimi okužbami, so pokazali, da je ozdravelo 85 % bolnikov (275 od 325), ki so prejemali zdravilo Doribax, v primerjavi s 84 % bolnikov (260 od 309), ki so prejemali meropenem;
• looking at the results of the two studies in nosocomial pneumonia taken together, 75% of the patients receiving Doribax were cured (195 out of 260), compared with 72% of the patients taking piperacillin/tazobactam or imipenem (174 out of 241);
• skupni rezultati obeh študij, pri katerih so sodelovali bolniki z nozokomialno pljučnico, so pokazali, da je ozdravelo 75 % bolnikov (195 od 260), ki so prejemali zdravilo Doribax, v primerjavi z 72 % bolnikov (174 od 241), ki so prejemali piperacilin/tazobaktam ali imipenem;
Doribax has been studied in five main studies that compared Doribax with other antibiotics: • two studies compared Doribax with piperacillin/tazobactam or imipenem in a total of 979 patients
• v dveh študijah so zdravilo Doribax primerjali z piperacilinom/tazobaktamom ali imipenemom pri skupaj 979 bolnikih z nozokomialno pljučnico;
It has been authorised in the European Union since 4 April 2008.
V Evropski uniji je odobreno od 4. aprila 2008.
The full European Public Assessment Report for Effentora 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 Effentora je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is a well-known substance, which has been used to control pain for many years.
To je dobro znana učinkovina, ki se že mnogo let uporablja za obvladovanje bolečine.
The duration of treatment was determined by the time needed by each patient to control 9 episodes of breakthrough pain within a 21-day period.
Trajanje zdravljenja je bilo odvisno od časa, ki ga je posamezen bolnik potreboval za nadzor 9 epizod prebijajoče bolečine v obdobju 21 dni.
Each patient ranked their pain intensity on a scale of 0 to 10.
Vsak bolnik je ocenil intenzivnost svoje bolečine z oceno od 0 do 10.
In all of the studies, the main measure of effectiveness was the change in pain intensity in the 60 minutes after taking the tablet.
Glavno merilo učinkovitosti v vseh študijah je bila sprememba intenzivnosti bolečine v 60 minutah po zaužitju tablete.
Effentora is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Zdravilo Effentora je na voljo v obliki „bukalnih tablet“ (tablet, ki se raztopijo v ustih).
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili potem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data submitted were not sufficient to address the Committee's concerns.
Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, potem ko je CHMP izrazil mnenje, da predloženi podatki niso bili zadostni, da bi odpravili zadržke Odbora.
The applicant presented data from 3 main studies in adults with breakthrough pain already using opioids.
Družba je predložila podatke iz 3 glavnih študij pri odraslih bolnikih s prebijajočo bolečino, ki so že uporabljali opioide.
The third study, which lasted for 12 weeks, looked at the effects of Effentora in 148 patients with non-cancer-related longterm pain.
V tretji študiji, ki je trajala 12 tednov, so preučevali učinke zdravila Effentora pri 148 bolnikih z dolgotrajno bolečino, ki ni bila povezana z rakom.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Effentora.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Effentora.
Once absorbed, fentanyl acts on receptors in the brain and spinal cord to control pain.
Po absorpciji začne fentanil delovati na receptorje v možganih in hrbtenjači ter tako preprečuje bolečino.
The effects of Effentora were compared with those of placebo (a dummy treatment) in 79 patients with neuropathic pain (pain due to nerve damage) in one study, and in 77 patients with lowback pain in a second study.
V prvi študiji so učinke zdravila Effentora primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 79 bolnikih z nevropatsko bolečino (bolečino zaradi poškodbe živca), v drugi študiji pa pri 77 bolnikih z bolečino v križu.
On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.
je 11. julija 2013 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo Effentora, s katero bi razširili zdravljenje prebijajoče bolečine na odrasle bolnike s kronično (dolgotrajno) trdovratno bolečino, ki ni posledica raka.
There are no consequences on the use of Effentora in its authorised indication.
Umik nima nobenih posledic za uporabo zdravila Effentora pri odobreni indikaciji.
The Committee also had concerns that the patients in the studies had high levels of background pain and might not have been representative of the intended treatment group, which consists of patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment.
Prav tako je bil zaskrbljen zaradi dejstva, da so imeli bolniki v študijah visoke stopnje osnovne bolečine in zato morda niso bili značilni predstavniki ciljne skupine, ki naj bi uporabljala zdravilo in jo sestavljajo bolniki, ki doživljajo prebijajočo bolečino, vendar pa osnovno bolečino dobro nadzorujejo z običajnimi opioidi.
It is already used to treat ‘breakthrough' pain in adults with cancer who are using opioid painkillers to control long-term cancer pain.
Zdravilo se že uporablja za zdravljenje „prebijajoče“ bolečine pri odraslih bolnikih z rakom, ki uporabljajo opioide za nadzor dolgotrajne bolečine zaradi raka.
The CHMP considered that, although the use of Effentora is accepted in cancer patients who have limited survival, further data were needed to support its safe use in adults with non-cancer-related pain, who have normal life expectancy and may need long-term treatment.
CHMP je menil, da so kljub dejstvu, da je uporaba zdravila Effentora sprejemljiva pri bolnikih z rakom, ki imajo omejene možnosti preživetja, potrebni dodatni podatki, ki bi podprli varno uporabo zdravila pri odraslih bolnikih z bolečino, ki ni povezana z rakom, pri katerih se pričakuje običajna življenjska doba in bi lahko potrebovali dolgoročno zdravljenje.
The Committee noted that several cases of misuse or abuse of the medicine had been reported in the studies, and was concerned about the risk of addiction in non-cancer patients when using Effentora in the long term.
Odbor je ugotovil, da so v študijah poročali o več primerih napačne uporabe ali zlorabe zdravila, zato je bil zaskrbljen glede tveganja za odvisnost bolnikov brez raka pri dolgoročni uporabi zdravila Effentora.
Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
O prebijajoči bolečini govorimo, ko bolnik občuti nenadno dodatno bolečino, čeprav uporablja zdravila proti bolečinam.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil zadržke in je začasno menil, da zdravila Effentora ni mogoče odobriti za zdravljenje prebijajoče bolečine pri odraslih bolnikih z dolgotrajno bolečino, ki ni posledica raka.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Effentora in patients with non-cancer-related long-term pain did not outweigh its risks.
Zato je CHMP v času umika menil, da koristi zdravila Effentora pri bolnikih z dolgotrajno bolečino, ki ni povezana z rakom, ne odtehtajo z njim povezanih tveganj.
What was Effentora expected to be used for?
Za kaj naj bi se zdravilo Effentora uporabljalo?
Effentora was also expected to be used to treat breakthrough pain in adults with long-term persistent pain from causes other than cancer, who were already receiving regular treatment with opioids to control their persistent pain.
Zdravilo Effentora naj bi se uporabljalo tudi za zdravljenje prebijajoče bolečine pri odraslih bolnikih z dolgotrajno trdovratno bolečino, ki ni posledica raka, ki so za nadzor trdovratne bolečine že prejemali običajno zdravljenje z opioidi.
In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Zdravilo Effentora se daje v obliki bukalnih tablet, tako da se fentanil absorbira skozi ustno sluznico.
In adults with long-term pain due to causes other than cancer, Effentora was expected to work in the same way as it does in adults with cancer pain.
Zdravilo Effentora naj bi pri odraslih bolnikih z dolgotrajno bolečino, ki ni posledica raka, delovalo na enak način kot pri odraslih bolnikih z bolečinami zaradi raka.
How was Effentora expected to work?
Kako naj bi zdravilo Effentora delovalo?
What is happening with Effentora for the treatment ‘breakthrough' pain in adults with cancer?
„prebijajoče“ bolečine pri odraslih bolnikih z rakom?
Content Package size Withdrawal Period
Vsebina Velikost pakiranja
The main studies lasted for two to four weeks.
Glavne študije so trajale dva do štiri tedne.
The marketing authorisation was renewed on 12 March 2004 and on 12 March 2009.
Dovoljenje za promet z zdravilom je bilo obnovljeno 12. marca 2004 in 12. marca 2009.
It is available as capsules (white and brown: 5 mg; white: 10 mg).
Na voljo je v obliki kapsul (bele in rjave: 5 mg; bele: 10 mg).
Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients.
Zdravilo Sonata so proučevali v skupaj 14 študijah, v katerih je sodelovalo skoraj 3 500 odraslih in starejših bolnikov.
Other information about Sonata:
Druge informacije o zdravilu Sonata:
Treatment with Sonata should be as short as possible and should last for no more than two weeks.
Zdravljenje z zdravilom Sonata mora biti čim krajše in naj ne traja več kot dva tedna.
Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Živčni prenašalci, kot je GABA, so kemijske snovi, ki omogočajo živčnim celicam medsebojno komunikacijo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SONATA EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) SONATA Povzetek EPAR za javnost
Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain.
Zaleplon se kemijsko razlikuje od benzodiazepinov, vendar učinkuje na iste receptorje v možganih.
The European Commission granted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999.
Evropska komisija je dovoljenje za promet z zdravilom Sonata, veljavno po celotni Evropski uniji, odobrila dne 12. marca 1999.
The main measure of effectiveness was the time taken to fall asleep.
Glavno merilo učinkovitosti je bil čas, potreben, da je bolnik zaspal.
The recommended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.
Priporočeni odmerek je 10 mg, razen pri starejših ali osebah z blagim ali zmernim obolenjem jeter, ki naj vzamejo 5-miligramski odmerek.
The Committee recommended that Sonata be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Sonata odobri dovoljenje za promet.
It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them.
Je agonist receptorjev gama-aminomaslene kisline (GABA), kar pomeni, da se veže na receptorje za živčne prenašalce GABA in jih aktivira.
By activating its receptors, zaleplon increases GABA's effects, which encourages sleep.
Zaleplon z aktiviranjem receptorjev poveča učinke GABA, kar spodbuja spanec.
For more information, see the Package Leaflet.
Za več informacij glejte navodilo za uporabo.
It is used only when the insomnia is severe, disabling or causing extreme distress.
Uporablja se samo, kadar je nespečnost huda in osebo onesposobi ali ji povzroča izjemno neugodje.
What benefit has Sonata shown during the studies?
Kakšne koristi je zdravilo Sonata izkazalo med študijami?
No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine's effects.
Uživanje hrane hkrati z zdravilom Sonata ali tik pred tem ni priporočljivo, saj lahko zmanjša učinke zdravila.
Some studies also looked at the time spent asleep and sleeping patterns.
Nekatere študije so merile tudi trajanje spanja in vzorce spanja.