natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union, for Monotard to Novo Nordisk A/S in on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Monotard, veljavno po vsej Evopski uniji, odobrila družbi Novo Nordisk A/S dne 7. oktobra 2002.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MONOTARD EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) MONOTARD Povzetek EPAR za javnost
If convenient it may also be given in the abdominal wall (tummy), the buttocks or the deltoid region (shoulder).
Če je primerno, se lahko daje tudi v abdominalno steno (trebuh), zadnjico ali predel deltoidne mišice (rame).
Monotard is a long-acting insulin, it can be given as a once daily or twice daily injection, with or without a fast-acting insulin (at meal times), according to the doctor's recommendation.
Zdravilo Monotard je insulin z dolgotrajnim delovanjem in ga lahko dajemo z injekcijo enkrat ali dvakrat dnevno z ali brez insulina s hitrim delovanjem (v času obroka) v skladu s priporočili zdravnika.
The studies measured the level of fasting blood sugar or a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood sugar is controlled.
V raziskavah so merili raven sladkorja v krvi na tešče ali tiste snovi v krvi (glikoziliranega hemoglobina, HbA1c), ki nam pokaže, kako dobro je raven sladkorja v krvi nadzorovana.
The Committee for Medicinal products for Human Use (CHMP) decided that Monotard's benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Monotard pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
What benefit has Monotard shown during the studies?
Kakšne koristi je zdravilo Monotard izkazalo med raziskavami?
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Nadomestni insulin deluje na enak način kot naravno proizveden insulin in omogoča, da lahko glukoza vstopi iz krvi v celico.
Monotard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Zdravila Monotard ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) človeški insulin (rDNA) ali katero koli drugo sestavino.
Monotard has been studied in both type 1 and type 2 diabetes, and it has been compared to other types of insulin (porcine, human).
Zdravilo Monotard so raziskali tako za sladkorno bolezen tipa 1 kot tudi tipa 2 in ga primerjali z drugimi vrstami insulina (prašičjim, človeškim).
Monotard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Odmerke zdravila Monotard bo morda potrebno prilagoditi, če se zdravilo jemlje istočasno s številnimi drugimi zdravili, ki vplivajo na koncentracijo sladkorja v krvi (celoten seznam le-teh najdete v Navodilih za uporabo).
What is the risk associated with Monotard?
Kakšna tveganja so povezana z zdravilom Monotard?
Monotard can be used in type 1 diabetes, when the pancreas cannot produce insulin, and in type 2 diabetes, when the body is not able to use insulin effectively.
Lahko se uporablja za zdravljenje sladkorne bolezni tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina, in sladkorne bolezni tipa 2, pri kateri telo insulina ni zmožno učinkovito uporabiti.
Monotard is used in patients with diabetes mellitus.
Zdravilo Monotard se uporablja za bolnike s sladkorno boleznijo.
Monotard is an insulin suspension for injection.
Zdravilo Monotard je suspenzija insulina za injiciranje.
Monotard was effective for both Type 1 and Type 2 diabetes.
Zdravilo Monotard se je izkazalo kot učinkovito tako za sladkorno bolezen tipa 1 kot tudi tipa 2.
Why has Monotard been approved?
Zakaj je bilo zdravilo Monotard odobreno?
Monotard may cause hypoglycaemia (low blood sugar).
Zdravilo Monotard lahko povzroči hipoglikemijo (nizko koncentracijo sladkorja v krvi).
Monotard is supplied as 40 or 100 IU strengths in vials.
Monotard je na voljo v vialah jakosti 40 ali 100 mednarodnih enot (IU).
Monotard contains insulin mixed with another substance, zinc, in particles from which the insulin is absorbed much more slowly during the day; and this gives Monotard a longer duration of action.
Zdravilo Monotard vsebuje insulin, pomešan z drugo snovjo, in sicer z delci cinka, iz katerega se insulin tekom dneva absorbira mnogo počasneje, kar podaljša čas delovanja zdravila Monotard.
They recommended that Monotard be given marketing authorisation.
Zato je priporočil, da se za zdravilo Monotard podeli dovoljenje za promet z zdravilom.
Monotard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Z uporabo zdravila Monotard se je znižala raven HbA1c, kar kaže na to, da je bila raven sladkorja v krvi vzdrževana na podobnih ravneh kot pri uporabi drugih vrst človeškega insulina.
The full EPAR for Monotard is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Monotard je na voljo tukaj.
Monotard contains the active ingredient insulin human (rDNA).
Zdravilo Monotard vsebuje zdravilno učinkovino človeški insulin (rDNA).
How has Monotard been studied?
Kako je bilo zdravilo Monotard raziskano?
Monotard is given subcutaneously (under the skin) by injection, usually in the thigh.
Zdravilo Monotard se daje s subkutano (podkožno) injekcijo, navadno v stegno.
For the full description of the side effects reported with Monotard, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Monotard, najdete v Navodilih za uporabo.
Monotard is a replacement insulin which identical to the insulin made by the pancreas .The active ingredient of Monotard, insulin human (rDNA), is produced by a method known as ‘recombinant technology'.
Zdravilno učinkovino zdravila Monotard, človeški insulin (rDNA), izdelujejo z metodo, znano pod imenom “rekombinantna tehnologija”.
What is Monotard used for?
Za kaj se zdravilo Monotard uporablja?
How is Monotard used?
Kako se zdravilo Monotard uporablja?
What is Monotard?
Kaj je zdravilo Monotard?
How does Monotard work?
Kako zdravilo Monotard deluje?
(EU) MA Number Invented name
EU(MA) številka
Further information on Slenyto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Slenyto so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The doctor should review treatment regularly, at least every 6 months, and only continue treatment if the patient is benefits from it.
Zdravnik mora redno, vsaj vsakih šest mesecev, pregledovati zdravljenje in ga nadaljevati le, če bolniku koristi.
The side effects seen with the medicine over 2 years appear mild or moderate but more data are needed on longer term safety.
Neželeni učinki, ki so jih opazili pri zdravilu v dveh letih, so blagi ali zmerni, vendar je potrebnih več podatkov o dolgoročni varnosti.
What measures are being taken to ensure the safe and effective use of Slenyto?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Slenyto?
Slenyto is available as tablets (1 and 5 mg).
Zdravilo Slenyto je na voljo v obliki tablet (1 in 5 mg).
The European Medicines Agency decided that Slenyto's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Slenyto večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Why is Slenyto authorised in the EU?
Zakaj je bilo zdravilo Slenyto odobreno v EU?
Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night.
Njegove ravni v krvi se običajno povečajo, ko se začne temniti, in vrhunec dosežejo sredi noči.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Slenyto 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 Slenyto upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Slenyto is a medicine for treating insomnia (difficulty sleeping) in children and adolescents (2 to 18 years old) who have:
Slenyto je zdravilo za zdravljenje nespečnosti (težav s spanjem) pri otrocih in mladostnikih (starih od dveh do 18 let), ki imajo:
The medicine contains the active substance melatonin.
Zdravilo vsebuje učinkovino melatonin.
What are the risks associated with Slenyto?
Kakšna tveganja so povezana z zdravilom Slenyto?
What is Slenyto and what is it used for?
Kaj je zdravilo Slenyto in za kaj se uporablja?
Side effects reported with Slenyto are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Slenyto, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The normal dose is 2 mg taken 30 minutes to one hour before bedtime.
Običajni odmerek je 2 mg, ki ga bolnik vzame 30 minut do eno uro pred spanjem.
• Smith-Magenis syndrome, a condition that can lead to learning difficulties.
• sindrom Smith-Magenis, tj. stanje, ki lahko povzroča učne težave.
• autism spectrum disorder (ASD), a range of conditions that affects the patient's social interactions;
• motnjo avtističnega spektra (ASD), tj. različna stanja, ki vplivajo na bolnikove socialne stike,
An overview of Slenyto and why it is authorised in the EU
Pregled zdravila Slenyto in zakaj je odobreno v EU
All patients had previously tried other measures, such as keeping to a regular sleeping routine, which did not work.
Vsi bolniki so predhodno že preizkusili druge ukrepe, kot so redna spalna rutina, vendar niso učinkovali.
For more information about using Slenyto, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Slenyto glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Patients with developmental conditions may produce less melatonin, leading to the development of insomnia.
Bolniki z razvojnimi težavami lahko tvorijo manj melatonina, kar privede do nespečnosti.
Melatonin is involved in coordinating the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep.
Melatonin sodeluje pri usklajevanju spalnega cikla telesa, tako da deluje na celice v določenih predelih možganov in pomaga pri uspavanju.
As for all medicines, data on the use of Slenyto are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Slenyto stalno spremljajo.
The most common side effects with Slenyto (which may affect up to 1 in 10 people) are sleepiness, tiredness, mood swings, headache, irritability, aggression and feeling hungover.
Najpogostejši neželeni učinki zdravila Slenyto (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so zaspanost, utrujenost, nihanja razpoloženja, glavobol, razdražljivost, agresivnost in občutek, podoben občutku po prekomernem zaužitju alkohola.
In addition, children who took Slenyto fell asleep around 38 minutes earlier than normal while those taking placebo fell asleep 13 minutes earlier.
Poleg tega so otroci, ki so jemali zdravilo Slenyto, zaspali približno 38 minut prej kot običajno, otroci, ki so jemali placebo, pa 13 minut prej.
The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available.
Delež otrok z nevrološkimi boleznimi, kot sta motnja avtističnega spektra (ASD) in sindrom SmithMagenis, ki hkrati trpijo tudi zaradi nespečnosti, je velik, na voljo pa ni veliko zdravil.
Other information about Slenyto
Druge informacije o zdravilu Slenyto
What benefits of Slenyto have been shown in studies?
Kakšne koristi zdravila Slenyto so se pokazale v študijah?
Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.
Ker se melatonin iz zdravila Slenyto sprošča počasi, v obdobju nekaj ur, posnema naravno nastajanje melatonina v telesu.
The dose can be increased up to a maximum of 10 mg if the medicine is not working well enough.
Če zdravilo ne učinkuje dovolj dobro, se odmerek lahko poveča do največ 10 mg.
The active substance in Slenyto, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Učinkovina v zdravilu Slenyto, melatonin, je naravni hormon, ki ga običajno proizvaja žleza v možganih, imenovana češerika.
Slenyto has been shown to be effective at improving sleeping time in children and adolescents with neurological conditions, including autism spectrum disorder and Smith-Magenis syndrome.
Dokazali so, da je zdravilo Slenyto učinkovito pri izboljšanju časa spanja pri otrocih in mladostnikih z nevrološkimi boleznimi, vključno z motnjo avtističnega spektra in sindromom Smith-Magenis.
Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.
Zdravilo Slenyto se uporablja, ko drugi ukrepi, kot so redna spalna rutina, niso učinkoviti.
In a main study of 125 patients, those given Slenyto over 13 weeks slept on average for 51 extra minutes of sleep a night compared with and 19 extra minutes for those given placebo (a dummy treatment).
V glavni študiji s 125 bolniki so bolniki, ki so 13 tednov prejemali zdravilo Slenyto, spali povprečno 51 minut na noč več, bolniki, ki so prejemali placebo (zdravilo brez učinkovine), pa 19 minut več.
Slenyto increases levels of melatonin in the blood, helping them to sleep.
Zdravilo Slenyto poveča ravni melatonina v krvi in tako bolnikom pomaga zaspati.
How is Slenyto used?
Kako se zdravilo Slenyto uporablja?
Slenyto has been shown to improve sleeping times in these patients, with patients taking Slenyto sleeping for an extra 51 minutes a night compared with an extra 19 minutes with placebo.
Dokazali so, da zdravilo Slenyto pri teh bolnikih izboljša čas spanja, saj so bolniki, ki so prejemali zdravilo Slenyto, spali 51 minut več, bolniki, ki so prejemali placebo, pa 19 minut več.
How does Slenyto work?
Kako zdravilo Slenyto deluje?
16 December 2014 EMA/785229/2014 corr1
16. december 2014 EMA/785229/2014
The review of polymyxin-based medicines was initiated on 16 September 2013 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Pregled zdravil, ki vsebujejo polimiksine, se je začel 16. septembra 2013 na zahtevo Evropske komisije v skladu s členom 31 Direktive 2001/83/ES.
Currently, products containing colistimethate sodium for use by injection or by inhalation as a solution or as a mist (nebulised) are approved under various trade names in Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom.
Trenutno so zdravila, ki vsebujejo natrijev kolistimetat in se uporabljajo z injiciranjem ali v obliki raztopine ali meglice (s pomočjo nebulatorja) za inhaliranje, pod različnimi trgovskimi imeni odobrena v Avstriji, Belgiji, Bolgariji, na Hrvaškem, v Češki republiki, na Danskem, v Estoniji, Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu.
• Patients who have any questions about their treatment should consult their doctor or pharmacist.
• Bolniki, ki imajo kakršna koli vprašanja o zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
• Dosage should be in line with relevant treatment guidelines.
• Odmerjanje mora biti skladno z ustreznimi smernicami za zdravljenje.
The CHMP opinion was forwarded to the European Commission, which issued a final decision valid throughout the EU on 16 December 2014.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 16. decembra 2014 izdala končni sklep, ki velja za celotno EU.
However, it was considered that in the interim the product information should be updated throughout the EU to reflect what was currently known.
Vendar pa je bilo ocenjeno, da je treba v tem času posodobiti informacije o zdravilu po vsej EU, da se vključi vse, kar je trenutno znanega.
Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly.
Kritično bolnim bolnikom je treba predpisati večji začetni (polnilni) odmerek, da se hitreje zagotovi učinkovita raven antibiotika v telesu.
Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics
Izdana so bila priporočila za varno uporabo pri bolnikih z resnimi okužbami, odpornimi proti standardnim antibiotikom
To address the differences in the way in which the strength of colistimethate sodium and colistin are expressed in the EU and in other regions such as the USA and Australia, which has led to errors in reporting in the medical literature and could potentially lead to serious medication errors, the following table will be included in the product information:
Da bi odpravili razlike v načinu izražanja jakosti natrijevega kolistimetata in kolistina v EU in na drugih območjih, kot so ZDA in Avstralija, zaradi katerih je prihajalo do napak pri poročanju v medicinski literaturi in ki bi lahko povzročile resne napake pri zdravljenju, bo v informacije o zdravilu vključena naslednja razpredelnica:
Colistin-base activity (CBA) (mg)1
Aktivnost kolistinske baze (mg)1
The Agency's recommendations are based on a review of the available clinical, pharmacological and pharmacokinetic data, although significant gaps still exist, particularly with regard to the pharmacokinetics in special populations such as children and patients with renal impairment.
Priporočila agencije temeljijo na pregledu razpoložljivih kliničnih, farmakoloških in farmakokinetičnih podatkov, čeprav precej podatkov še vedno manjka, zlasti tistih o farmakokinetiki pri posebnih populacijah, kot so otroci in bolniki z okvaro ledvic.
Polymyxin-based products have been available since the 1960s, but their use quickly decreased due to the availability of antibiotics with fewer potential side effects.
Zdravila, ki vsebujejo polimiksine, so na voljo od šestdesetih let prejšnjega stoletja, vendar se je njihova uporaba hitro zmanjšala, ko so postali na voljo antibiotiki, ki imajo manj možnih neželenih učinkov.
The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information.
Odbor je priporočil, da se odmerki vedno izražajo v mednarodnih enotah (i.e.), ker pa so odmerki natrijevega kolistimetata lahko izraženi na različne načine, mora biti v informacije o zdravilu vključena razpredelnica za pretvorbo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data about the pharmacokinetics, effectiveness and safety of these medicines.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je pregledal razpoložljive podatke o farmakokinetiki, učinkovitosti in varnosti teh zdravil.
European Medicines Agency completes review of polymyxin-based medicines
Evropska agencija za zdravila zaključila pregled zdravil, ki vsebujejo polimiksine
This has led to a resurgence in recent years in the use of polymyxins in patients with few other options.
Zaradi tega se je v zadnjih letih ponovno povečala uporaba polimiksinov pri bolnikih, ki imajo malo drugih možnosti.
1 Nominal potency of the drug substance = 12.500 IU/mg
Nominalna jakost zdravilne učinkovine zdravila = 12.500 i.e./mg.
The review of these data was conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which considered them and formulated the Agency's final opinion.
Pregled teh podatkov je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja, povezana z zdravili za uporabo v humani medicini, ki je proučil podatke in oblikoval končno mnenje agencije.
On 23 October 2014 the European Medicines Agency (EMA) completed a review of the safety and effectiveness of products containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to their product information to ensure safe use in the treatment of serious infections that are resistant to standard antibiotics.
Evropska agencija za zdravila (EMA) je 23. oktobra 2014 zaključila pregled varnosti in učinkovitosti zdravil, ki vsebujejo antibiotik kolistin ali natrijev kolistimetat (znana kot polimiksina), ter priporočila spremembe informacij o zdravilu za zagotovitev varne uporabe pri zdravljenju resnih okužb, ki so odporne proti standardnim antibiotikom.
The recommended dose in adults is 1 to 2 million IU given 2 to 3 times a day, and in children 0.5 to 1 million IU twice daily, adjusted according to the severity of the condition and the response.
Priporočeni odmerek za odrasle je od 1 do 2 milijona i.e., ki se daje 2- do 3-krat na dan, za otroke pa od 0,5 do 1 milijona i.e. dvakrat na dan, prilagojeno glede na resnost bolezni in odziv.
The European Commission therefore requested the EMA to review the available data and make recommendations on whether the marketing authorisations for these medicines should be changed and the product information amended appropriately.
Evropska komisija je zato zaprosila Evropsko agencijo za zdravila, naj pregleda razpoložljive podatke in poda priporočila o tem, ali bi bilo treba spremeniti dovoljenja za promet s temi zdravili in ustrezno posodobiti informacije o zdravilu.
• In children, the suggested dose is 75,000 to 150,000 IU/kg daily, in 3 divided doses.
• Predlagani odmerek za otroke je od 75.000 do 150.000 i.e./kg na dan v 3 deljenih odmerkih.
Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).
Čeprav so bili podatki zelo omejeni, je Odbor priporočil odmerke za uporabo pri bolnikih, ki imajo težave z ledvicami, in otrocih ter podal smernice za odmerjanje pri odraslih, ki zdravilo prejmejo neposredno v tekočino, ki obdaja možgane ali hrbtenjačo (intratekalno ali intraventrikularno injiciranje).
Research currently underway may provide further information on pharmacodynamics and pharmacokinetics of these medicines to improve the evidence-base behind any dose recommendations.
Raziskava, ki trenutno poteka, bi lahko zagotovila dodatne podatke o farmakodinamiki in farmakokinetiki teh zdravil, s katerimi bi okrepili dokaze, na katerih temeljijo vsa priporočila za odmerjanje.
• The product information for medicines containing colistimethate sodium will be updated as required to take these recommendations into account.
• Informacije o zdravilu za zdravila, ki vsebujejo natrijev kolistimetat, bodo ustrezno posodobljene, tako da se bodo upoštevala ta priporočila.
Based on the limited available evidence the recommended dose in adults is 9 million IU daily in 2 or 3 divided doses as a slow intravenous infusion; in critically ill patients a loading dose of 9 million IU should be given.
Glede na omejene razpoložljive dokaze je priporočeni odmerek za odrasle 9 milijonov i.e. na dan v 2 ali 3 deljenih odmerkih, ki se dajejo s počasno intravensko infuzijo; kritično bolnim bolnikom je treba dati polnilni odmerek 9 milijonov i.e.
In addition, colistimethate sodium has been approved in the EU for inhalation as a dry powder under the trade name Colobreathe.
Poleg tega je natrijev kolistimetat v EU odobren tudi v obliki suhega praška za inhaliranje pod trgovskim imenom Colobreathe.